Note that there is no such thing as adult-onset ADHD. Selling or giving away Azstarys may harm others and is against the law. It is unique because it is the first medication to combine dexmethylphenidate and serdexmethylphenidate. Patients on stimulants who develop exertional chest pain or unexplained syncope need further evaluation. To learn about other mild side effects, talk with your doctor or pharmacist, or read the drugs prescribing information. Nias Story, Aspergers or ADHD? The use of Azstarys should be avoided on the day of surgery if halogenated anesthetics will be used. Talk to your doctor before starting Azstarys if you or your child has circulation problems in fingers and toes. WARNING: AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to dependence. Dependence on a drug means your body gets used to a drug and needs it to function as usual. If the capsules cannot be swallowed whole, the capsule may be opened and the entire contents sprinkled onto 2 tablespoonfuls of applesauce or into 2oz (50mL) of water. Call your doctor for medical advice about side effects. Definition; PA: Prior Authorization Drugs that require prior authorization. But if you think youre having a medical emergency, call 911 or your local emergency number. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction. Below are some common questions about taking Azstarys. Do give a Like and consider subscribing if you found these videos useful.Thanks for watching!Video TagsPronunciation, Pronounce, Free, Dictionary, Learn, Study, Tutorial, Improve, Enhance, Guide, How to Say, How to, How do you, Speak, Speaking, Speech, Sound, English Language, Voice, Audio, Native Speaker, Scientific, Science, Technology, Medics, Medical, Medicine, Terminology, Disease, Disorders, Syndromes, Pathology, Pharmaceutical, Drugs, Treatment, Chemistry, Physics, Biology, Physiology, Hollywood, Bollywood, Cinema, Actors, Directors, Sports, Games, Companies, Corporate, Cars, Automotive, Vehicles, Places, Cities, States, FDA, US, USA, America, American, UK, United Kingdom, British, Norway, Australia, Canada, Switzerland, India, Denmark, New Zealand, Germany, Netherlands, Sweden, Spain, Russia, Japan, China, Korea, Belgium. Vyvanse and Mydayis are suitable long-acting amphetamines. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. All rights reserved. Healthline Media does not provide medical advice, diagnosis, or treatment. Azstarys contains serdexmethylphenidate, a prodrug of dexmethylphenidate, co-formulated with immediate-release dexmethylphenidate. It is expected to be available this summer. WARNING: AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to dependence. Pharmacological treatment of ADHD may be needed for extended periods. You have earned {{app.voicePoint}} points. Adderall 10 mg is approximately equivalent to Ritalin 20 mg. If applicable to a given patient, Prescription amphetamines and methylphenidates are all. Paradoxically, some patients with ADHD complain stimulants make them overly slowed or even zombified. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. These effects are called interactions. Certain factors can determine whether Azstarys is a good treatment option for you. Pregnancy registries collect data about the effects of certain drugs during pregnancy. Sudden death has been reported in association with stimulants at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. The contents can be sprinkled onto 2 tablespoons of applesauce. Azstarys comes as a capsule that you swallow. But some experts suggest that people living with ADHD have fewer dopamine receptors. individual needs, Each dosage strength is a different color, The AZSTARYS capsule is slightly smaller The dosage may be increased after one week to a dosage of 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate per day, or decreased after one week to a dosage of 26.1 mg serdexmethylphenidate/5.2 mg dexmethylphenidate per day, depending on response and tolerability. After a week of treatment, raters used the SKAMP-Combined rating scale to evaluate the children's attention and behavior in a classroom setting. There is a pregnancy registry for females who are exposed to ADHD medications, including Azstarys, during pregnancy. blood pressure and heart rate. Your doctor will evaluate your risk of misuse and risk of dependence before prescribing Azstarys. Predominantly inattentive ADHD usually does not tend to improve throughout adulthood. Children ages 710 years old taking stimulants 7 days per week throughout the year demonstrate growth retardation, averaging 2 cm, without evidence of growth rebound upon discontinuation of the stimulant. Circulation problems in fingers and toes (peripheral vasculopathy, including Raynauds phenomenon). The main purpose of the stimulant mnemonics in Cafer's Psychopharmacology: Visualize to Memorize 270 Medication Mascots is to help you differentiate the Adderalls (amphetamines) from the Ritalins (methylphenidates). SDX is a prodrug of dexmethylphenidate which has a delayed onset of action and a prolonged duration of effects compared to dexmethylphenidate. Your healthcare provider will decide whether Azstarys can be taken with other medicines. Azstarys can sometimes cause harmful effects in people who have certain conditions. Dosage may be increased to 52.3 mg/10.4 mg daily or decreased to 26.1 mg/5.2 mg daily after one week. And they want you to get the best care possible. | Source: We comply with the HONcode standard for trustworthy health information. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued. High blood pressure or heart rate. Mild side effects of many drugs may go away within a few days to a couple of weeks. If switching from other methylphenidate products, discontinue that treatment, and titrate with AZSTARYS using the titration schedule described above. 2005-2023 Healthline Media a Red Ventures Company. If its hard for you to read the label on your prescription, tell your doctor or pharmacist. For more information about the use of Azstarys for treating ADHD, talk with your doctor or pharmacist. For Neurodivergent Black Adults, Whats in a Diagnosis? Azstarys is a brand-name prescription medication. Prescribers can minimize risk of diversion (i.e., patients sharing their pills) by limiting supply to one extended-release capsule daily. Does taking Azstarys increase my childs risk of misusing drugs later in life? AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to dependence. The videos cover a diverse range of subjects with a specific focus on technical words that can be extremely challenging to pronounce correctly. If you have or have ever had depression, tell your doctor before you start taking Azstarys. Youll take Azstarys once daily in the morning. Register Sudden death has, if you or your child have mental (psychiatric) problems, or a family history of suicide, bipolar illness, or depression. Bronchospasm, rash, and pruritus have been reported in patients who received Azstarys. Our website services, content, and products are for informational purposes only. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. Keep AZSTARYS in a safe, AZSTARYS is a federally controlled substance (CII) because it can be abused or. For most individuals, the FDA maximum dose for a given stimulant is no more effective than a moderate dose. Prior to initiating treatment with AZSTARYS, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)]. March 02, 2021 23:31 ET The cash price for 100 generic Adderall 5 mg tablets costs about $14.00. In my research and practice, three properties are repeatedly cited by patients and their caregivers as being underserved by current ADHD medications: onset of action, duration of effect and consistency of therapy. hYmo6+`&PHvA.cPl*K48;``$GiIK aRI(-S>OJ%R@Pj(0(jZ&C!)gP'd:Zfb`Z3k2[ahmkX`PA%`!T?%}gCBX@CL+zx6PLxSVN,neTY~wIveyu]!3B|R#=+ _m;v:i^4&!vqYa\e6c>UeOA#@H$UuEu+%G,1)!3dUG:>5/i*)6 }XZc/Z^dN+?O;lS"5yH:O$aR9-`.~~S~D_q9buUCQ-es#56d_r?%o2WN4Qulj,VL&?y[GTe}A`x5F"Hu~ KE~d^%iJv"]Hh 9SI2"jF76`76d99OU You can try again. Children ages 710 years old taking stimulants 7 days per week throughout the year demonstrate, The main purpose of the stimulant mnemonics in. New or worse, if you or your child develop painful and prolonged erections (priapism), seek medical help right away. AZSTARYS is a central nervous system (CNS) stimulant prescription medicine for the treatment of Attention Deficit Hyperactivity. The norepinephrine reuptake inhibitor atomoxetine (Strattera) is noncontrolled and approved for ADHD but is substantially less effective than stimulants. Talk to your healthcare provider about. Azstarys is a central nervous system stimulant prescription medicine used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Corium, Inc. (Corium), a portfolio company of Gurnet Point Capital (GPC), will lead the commercialization of AZSTARYS per the definitive collaboration and license agreement (the License Agreement) between KemPharm and an affiliate of GPC. Controlled substances are classified by categories called Schedules, numbered I to V. Schedule I drugs have the highest potential for misuse and dependence, and Schedule V drugs have the lowest. Call your doctor for medical advice about side effects. Theyll also explain how much to take and how often. Slow-release stimulant formulations do not have pleasurable effects and can be more effective for ADHD than immediate-release formulations. In the evening, Azstarys gradually wears off. It may harm them, and it is against the law. Keep Azstarys and all medicines out of the reach of children. Take Azstarys 1 time each day in the morning with or without food. Especially tell your healthcare provider if you or your child take: Know the medicines that you or your child take. ADHD is a common. Those taking antihypertensive drugs in additional to Azstarys should have their blood pressure monitored. Azstarys capsules may be swallowed whole with water or other liquids. If you have questions or concerns about Azstarys being a controlled substance, talk with your doctor or pharmacist. if your child is having slowing of growth (height and weight). AZSTARYS TM is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. The dexmethylphenidate component starts working in 30 minutes. Available for Android and iOS devices. After both drugs in Azstarys take effect, your body will clear them. As a result of the FDAs approval of the AZSTARYS NDA, KemPharm has earned a regulatory milestone payment following FDA approval as provided under the License Agreement, and KemPharm is working with GPC to evaluate the related provisions and amounts. endstream endobj 297 0 obj <> endobj 298 0 obj <> endobj 299 0 obj <>stream Controlled substances are drugs regulated by the United States government because they may cause misuse and dependence. {{app.userTrophy[app.userTrophyNo].hints}}. Azstarys contains two drugs, dexmethylphenidate and serdexmethylphenidate. from Cafer's Psychopharmacology: Visualize to Memorize 270 Medication Mascots, Phonetic pronunciation: DEX meth uhl FEN i deyt / az STAR is. Do not take more Azstarys than your doctor prescribes. If you breastfeed while taking Azstarys, doctors will monitor your child for agitation and weight loss. But if they become bothersome, talk with your doctor or pharmacist. The complete label may also be downloaded in PDF format here:http://ml.globenewswire.com/Resource/Download/4f63af91-9427-40da-b881-82a5e22a0315. Administer AZSTARYS orally once daily in the morning with or without food [see Clinical Pharmacology (12.3)]. You can ask your healthcare provider or pharmacist for information that was written for healthcare professionals. The Schedule II stimulants (amphetamines and methylphenidates) have a Black Box Warning for risk of abuse and dependence. Disorder (ADHD) in people 6 years of age and older. Subscribe to learn and pronounce a new word each day! For children with severe ADHD, drug holidays may not be advisable. Disorder (ADHD) in people 6 years of age and older. Tell your doctor if youve had trouble with drug misuse in the past. Serious side effects from Azstarys can occur, but they arent common. Its recommended that you swallow the capsule whole. Patients with ADHD have. Priapism has occurred with. blood pressure medicines (anti-hypertensive). Taking periodic drug holidays from the stimulant can minimize stunting of growth. For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor. 7090% of individuals with multiple sclerosis experience fatigue, which may be responsive to stimulants. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Before you start taking Azstarys, tell your doctor if you have a history of psychosis. These stimulants can also be more effective for ADHD by providing a slow-rising and constant steady-state level of stimulant. You can take Azstarys with or without food. Last updated on Sep 1, 2021. Misuse can lead to an addiction to Azstarys, even at prescribed doses. You can also check out this article to learn more about saving money on prescriptions. In addition, KemPharm has received FDA approval for APADAZ, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. If you have or have had psychosis, stimulants like Azstarys may worsen your symptoms of this condition. Your healthcare provider may change the dose if needed. ET, to discuss FDA approval of the AZSTARYS NDA. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. Never give it to anyone else because it may cause death or harm them. Choose one way to take it and stick to this pattern daily. ADDitude collaborates closely with leading medical experts to publish accurate, clear, and authoritative content that millions of readers trust and share. Risk of misuse and risk of dependence. KemPharm utilizes its proprietary LAT technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. Dry mouth is a common side effect. They include methylphenidate (Concerta, Ritalin) and dexmethylphenidate (Focalin). Stimulants rarely cause Raynaud's phenomenon, which is expected to resolve with dose reduction or discontinuation. Dosage form: Capsules This is a serious warning from the Food and Drug Administration (FDA) about drug effects that may be dangerous. For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor. It is a combination of two methylphenidate stimulants30% dexmethylphenidate (available generically as Focalin) and 70%, The dexmethylphenidate component starts working in, The principal target symptoms for treatment of attention deficit hyperactivity disorder (ADHD) are inattention and impulsivity. Active ingredients: serdexmethylphenidate and dexmethylphenidate The table below summarizes some of the similarities and differences between these drugs. Or you may open a capsule and sprinkle the contents into applesauce or 2 ounces (50 milliliters) of water. AZSTARYS is a central nervous system (CNS) stimulant prescription medicine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Word of the day - in your inbox every day, 2023 HowToPronounce. Tolerance to the antidepressant effect is expected to develop in 2 to 4 weeks. Let your doctor know if your child is having slowing of growth (height and weight) while taking Azstarys. Psychostimulants are sympathomimetics that mimic the action of norepinephrine (NE) and dopamine (DA) to activate the sympathetic (fight or flight) nervous system. It is not known if Azstarys may harm your unborn baby. Call your doctor for medical advice about side effects. * An active ingredient is what makes a drug work. Adderall also comes as an extended-release capsule called Adderall XR. Azstarys has a boxed warning for risk of misuse and risk of dependence. This can help with morning routines before school or work and then last throughout the day. If youve ever misused alcohol, Azstarys may not be the right drug for you. Examples include taking more than the recommended dosage and taking a medication prescribed to someone else. fingers or toes may feel numb, cool, or painful, fingers or toes may change color from pale, to blue, to red. Generic name: dexmethylphenidate and serdexmethylphenidate In overdose, stimulants can cause heart failure, seizure, and stroke. Let your doctor know if you or your child is pregnant or plan to become pregnant. Symptoms of a mild allergic reaction can include: A more severe allergic reaction is rare but possible. A pregnancy registry is available for drugs that treat attention deficit hyperactivity disorder (ADHD), such as Azstarys. Tags: ADHD Etc., medication, treating adults, treating kids. Dosage may be increased after one week to 52.3 mg/10.4 mg once daily. Find answers to some commonly asked questions about Azstarys. Selling or giving away . Your doctor will determine whether its safe for you to take this drug. Azstarys lasts throughout the day to treat the symptoms of ADHD. Stimulants decrease appetite by increasing adrenergic and dopaminergic activity in the hypothalamus. hb```e``rc`a`ae`@ +s,13(0xJZ-bR5;u!s,[n2_`'W+P$S:4- dp6i\".ZcM2r-p79tB$sZYSxg=[t3aQff] 8:XShh @* D2E,*:4:$\, Xt[U@m|qz63*33.hbpCXx*4# wq To learn more about this boxed warning, see the Can Azstarys be misused or cause dependence? section below. Our mission is to be your trusted advisor, an unwavering source of understanding and guidance along the path to wellness. ADHD symptoms are best relieved when DAT occupancy is gradual, non-saturated, constant and prolonged. Prescription amphetamines and methylphenidates are all Schedule II controlled substances, the same level of restriction as opioid pain medications. Brain fog is a common symptom of ADHD, read on to learn the current research and treatment options. Before your appointment, write down questions such as: How will Azstarys affect my body, mood, or lifestyle? Interested participants and investors may access the conference call by dialing either: An audio webcast with slide presentation will be accessible via the Investor Relations section of the Companys website,http://investors.kempharm.com/. Patients with ADHD have difficulty activating areas of the prefrontal cortex due to weak dopaminergic and noradrenergic transmission. The complete label for AZSTARYS, including prescribing information and important safety information, may be found at www.kempharm.com/pipeline-products/#kp415. Todays approval highlights both the value potential of SDX, our prodrug of d-MPH, and the ability of our LAT platform technology to develop new prodrugs of approved medications that improve one or more of the attributes of the parent drug. Swelling of the ear is also possible, and some people report severe skin reactions with Azstarys. This list does not contain all kinds of drugs that may interact with Azstarys. Here's a detailed look at the correlation between intelligence and. Does Azstarys cause long-term side effects? The Schedule II stimulants (amphetamines and methylphenidates) have a Black Box Warning for risk of abuse and dependence. Formerly referred to as KP415, Azstarys comprises serdexmethylphenidate (SDX), KemPharm's prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. AZSTARYSTM is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. Some people may have an allergic reaction to Azstarys. Bipolar disorder. CELEBRATION, Fla., March 02, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for (NDA) AZSTARYS (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. Store Azstarys in a safe place and in a tightly closed container at room temperature between 68F to 77F (20C to 25C). All of the applesauce or water mixture should be swallowed within 10 minutes. all patients for hypertension and. Azstarys consists of SDX, KemPharm's prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. The serdexmethylphenidate component lasts for 13 hours. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. KemPharm, Conference Call and Live Audio Webcast Scheduled for Tomorrow, Wednesday, March 3, at 8:30 a.m. For treatment of ADHD there is no intervention nearly as effective as medication. Although adults with ADHD may be impaired by inattentive symptoms, ADHD is often not the focus of pharmacotherapy because of comorbid conditions. If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. Some of the stimulants are approved for children as young as age 3, but most are approved for ages 6 and above. WARNING: AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to dependence. KemPharms product portfolio is highlighted by AZSTARYS, an FDA-approved, once-daily treatment for attention deficit hyperactivity disorder (ADHD) which is based on serdexmethylphenidate, (SDX), KemPharms prodrug of d-methylphenidate (d-MPH). They can help you decide whether the benefits of taking Azstarys outweigh the possible risks to a child who is breastfed. (To learn more, see the Can Azstarys be misused or cause dependence? section below.). Your doctor may ask you questions about how much and how often you drink alcohol. Central nervous system (CNS) stimulants such as Azstarys have high potential for misuse and dependence. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. People with ADHD may have the following symptoms: To be diagnosed with ADHD, you must have these symptoms for at least 6 months. If you have serious side effects from Azstarys, call your doctor right away. What should be considered before taking Azstarys? Keep this medicine in a safe place to protect it from theft. This is best accomplished by a modestly dosed, slow-onset, long-duration stimulant formulation. In 2019, the methylphenidate segment of the ADHD market accounted for approximately 20 million prescriptions and$4.9 billionin sales. If you or your child has psychiatric problems, or a family history of suicide, bipolar illness, or depression, tell your doctor before starting Azstarys. Azstarys was approved in 2021 for treatment of ADHD in patients over age 6. It appears JavaScript is disabled in your browser. The principal target symptoms for treatment of attention deficit hyperactivity disorder (ADHD) are inattention and impulsivity. Dispose of remaining, unused, or expired Azstarys by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing. Corium does not endorse and makes no claim or warranty of, and is not responsible for, any information found in the linked website. Serious side effects of Azstarys that have been reported include: * For more information, see the Can Azstarys be misused or cause dependence? section below. To learn more about this side effect, see the Allergic reaction section below. If injected intravenously dexmethylphenidate is active but SDX is not. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Azstarys can be taken with or without food. Keep AZSTARYS in a safe place to prevent misuse and abuse. Azstarys dexmethylphenidate 5.2 mg / serdexmethylphenidate 26.1 mg (KP415 286). Or go to the nearest emergency room. AZSTARYS should be periodically discontinued to assess the pediatric patient's condition. Sudden death has, if you or your child have mental (psychiatric) problems, or a family history of suicide, bipolar illness, or depression. AZSTARYS consists of serdexmethylphenidate (SDX), KemPharms prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. If your heart rate is too high, your doctor may also prescribe medication to slow your heart rate. Azstarys is a once-daily central nervous system (CNS) stimulant ADHD medication approved for the treatment of ADHD symptoms in patients 6 years of age and older. Azstarys can interact with several kinds of drugs. Adjunctive interventions that may be beneficial include omega-3 fatty acids, sleep hygiene interventions, and cognitive behavioral therapy (CBT). It is possible to develop priapism upon stopping the stimulant, e.g., for a drug holiday. Factors to consider include those described below. If paradoxical aggravation of symptoms or other adverse reactions occur; the dosage should be reduced, or, if necessary, the drug should be discontinued. Psychosis. Amphetamine pictures include an amplifier, while methylphenidates are depicted as scantron sheets. allergic to serdexmethylphenidate, methylphenidate, or any of the ingredients in AZSTARYS. Azstarys may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD. SERDEXMETHYLPHENIDATE CHLORIDE 26.1mg, DEXMETHYLPHENIDATE HYDROCHLORIDE 5.2mg. While withdrawal from opioids is highly distressing, withdrawal from stimulants is less severe and mostly consists of fatigue, hypersomnia, irritability, and increased appetite. taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase, if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. See the end of this page for a complete list of ingredients. Do not take AZSTARYS if you or your child are: The most common side effects of AZSTARYS include: These are not all the possible side effects of AZSTARYS. Bipolar patients should be monitored closely for mood destabilization and the stimulant discontinued immediately if signs of mania arise. 6 (52/10.4 mg). Corium does not endorse and makes no claim or warranty of, and is not responsible for, any information found in the linked website. Although adults with ADHD may be impaired by inattentive symptoms, ADHD is often not the focus of pharmacotherapy because of comorbid conditions. Keep the empty AZSTARYS bottle somewhere youll be sure to see it, like next to your toothbrush, Designate a spot on your calendar to check off when you give your child their medicine, Set an alert on your cell phone or smartwatch, Connect AZSTARYS with an activity in your morning routine. It is not known if AZSTARYS may harm your unborn baby. You've got the pronunciation of AZSTARYS right. 0 These forward-looking statements include statements about the commercial launch of AZSTARYS, including the timing of launch, the regulatory milestone payment, and the potential clinical benefits of AZSTARYS.