Dextroamphetamine sulfate

Woburn, MA — April 6, 2026 — Azurity Pharmaceuticals, Inc. announced that ARYNTATM (lisdexamfetamine dimesylate) Oral Solution is now available in the United States for treating ADHD in adults and pediatric patients 6 years and older. Arynta, a ready-to-use lisdexamfetamine oral solution that may be stored at room temperature between 68°F to 77°F (20°C to 25°C),1 received FDA approval in June 2025. “Azurity Pharmaceuticals is proud to offer Arynta as an option for patients who need or prefer an oral liquid and are seeking flexibility in their treatment options,” said Ronald Scarboro, CEO of Azurity Pharmaceuticals. In pivotal Phase 3 clinical trials that evaluated the efficacy and safety of lisdexamfetamine across pediatric and adult patient populations, lisdexamfetamine demonstrated statistically significant efficacy for the core symptoms of hyperactive-impulsive and inattention in ADHD.1 As a prodrug of amphetamine, Arynta delivers reliable symptom control for up to 13 hours in children and up to 14 hours in adults, and its safety and tolerability profile is similar to that of other stimulant medication.1-5 Please read the full Prescribing Information, including Boxed Warning, and additional safety information at www.arynta.com. Azurity Pharmaceuticals is committed to serving overlooked patients, including those who have difficulty swallowing capsules or prefer a liquid form. It is reported that approximately 70% of children and about 30% of adolescents refuse or have difficulty swallowing tablets or capsules.6 Certain patient populations are more impacted than others. For example, about 40% of children with autism also have ADHD and many children with autism struggle with food texture hypersensitivity, which may make taking medication in capsule and sprinkle form a challenge.7-10 Arynta helps to address this need as part of Azurity’s innovative dose-form solutions. IMPORTANT SAFETY INFORMATION ARYNTATM (lisdexamfetamine dimesylate) Oral Solution, CII ARYNTA is a central nervous system (CNS) stimulant indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Moderate to severe binge eating disorder (BED) in adults. Limitations of Use: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older. ARYNTA is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of ARYNTA for the treatment of obesity have not been established. WARNING: ABUSE, MISUSE, AND ADDICTION ARYNTA has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including ARYNTA, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing ARYNTA, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout ARYNTA treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2)]. ADDITIONAL IMPORTANT SAFETY INFORMATION Do not take ARYNTA if you or your child are: Allergic to amphetamine products or any of the ingredients in ARYNTA. Taking, or have stopped taking in the last 14 days, a medicine called Monoamine Oxidase Inhibitor (MAOI). Being treated with the antibiotic linezolid or intravenous methylene blue. What are the possible side effects of ARYNTA? ARYNTA may cause serious side effects, including: Abuse, misuse, and addiction: ARYNTA has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of ARYNTA, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of ARYNTA or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with ARYNTA and will monitor you or your child during treatment. ARYNTA may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease. Your provider should check you or your child carefully for heart problems before starting treatment with ARYNTA. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Increased blood pressure and heart rate: Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with ARYNTA. Mental (psychiatric) problems: new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have or about a family history of suicide, bipolar illness, or depression. Slowing of growth (height and weight) in children: Children should have their height and weight checked often during treatment with ARYNTA. ARYNTA treatment may be stopped if your child is not growing or gaining weight as expected. Circulation problems in fingers and toes (Peripheral Vasculopathy, including Raynaud’s phenomenon): Signs and symptoms may include: fingers or toes may feel numb, cool, painful fingers or toes may change color from pale, to blue, to red Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Serotonin Syndrome: A potentially life-threatening problem called serotonin syndrome may happen when ARYNTA is taken with certain other medicines. Stop taking ARYNTA and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome: agitation fast heartbeat seizures sweating confusion tremors, stiff muscles, or muscle twitching changes in blood pressure nausea, vomiting, diarrhea flushing coma loss of coordination dizziness seeing or hearing things that are not real (hallucination) high body temperature (hyperthermia) New or worsening tics or worsening Tourette’s syndrome: Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with ARYNTA. Before taking ARYNTA, tell your doctor about all your medical conditions, including if you or your child: Have heart problems, heart disease, heart defects, or high blood pressure, or have a family history of sudden death or heart rhythm problems Have mental problems including psychosis, mania, bipolar illness, or depression or have a family history of suicide, bipolar illness, or depression Have circulation problems in fingers and toes Have kidney problems Have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome Are pregnant or plan to become pregnant. ARYNTA may harm the unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with ARYNTA. Are breastfeeding or plan to breastfeed. ARYNTA passes into breast milk. You should not breastfeed during treatment with ARYNTA. Talk to your healthcare provider about the best way to feed the baby during treatment with ARYNTA. Tell your healthcare provider about all the medicines that you or your child take, including: Prescription and over-the-counter medicines, vitamins, and herbal supplements. ARYNTA can affect the way other medicines work and other medicines may affect how ARYNTA works. Taking ARYNTA with other medicines can cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with ARYNTA. The most common side effects of ARYNTA: In children 6 to 17 years and adults with ADHD include decreased or loss of appetite, diarrhea, dry mouth, trouble sleeping, stomach pain, anxiety, weight loss, dizziness, irritability, nausea, and vomiting. In adults with BED include dry mouth, decreased appetite, constipation, anxiety, trouble sleeping, increased heart rate, and feeling restless. The Important Safety Information does not include all the information needed to use ARYNTA safely and effectively. Please see accompanying full Prescribing Information for ARYNTA. To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch. ARYNTATM is a trademark of Azurity Pharmaceuticals, Inc. ©2025 Azurity Pharmaceuticals, Inc. PP-ARY-US-0003 References Arynta [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc; 2025. Boellner SW, Stark JG, Krishnan S, Zhang Y. Pharmacokinetics of lisedexamfetamine dimesylate and its active metabolite, d-amphetamine, with increasing oral doses of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: a single-dose, randomized, open-label, crossover study. Clin Ther. 2010;32(2):252-264 Jasinski DR, Krishnan S. Abuse liability and safety of oral lisdexamfetamine dimesylate in individuals with a history of stimulant abuse. J Psychopharmacol. 2009;23(4):419–427. Jasinski DR, Krishnan S. Human pharmacology of intravenous lisdexamfetamine dimesylate: abuse liability in adult stimulant abusers. J Psychopharmacol. 2009;23(4):410–418. Kaland ME, Klein-Schwartz W. Comparison of lisdexamfetamine and dextroamphetamine exposures reported to U.S. poison centers. Clin Toxicol (Phila). 2015;53(5):477–485. Polaha J, Dalton WT 3rd, Lancaster BM. Parental report of medication acceptance among youth: implications for everyday practice. South Med J. 2008;101(11):1106-1112. Houghton R, Ong RC, Bolognani F. Psychiatric comorbidities and use of psychotropic medications in people with autism spectrum disorder in the United States. Autism Res. 2017;10(12):2037–2047. American Academy of Child and Adolescent Psychiatry. ADHD in Youth With ASD: Parents’ Medication Guide. Published 2023. Accessed July 7, 2025. https://www.aacap.org/App_Themes/AACAP/docs/resource_centers/resources/med_guides/ADHDwithASD_Web.pdf Cermak SA, Curtin C, Bandini LG. Food selectivity and sensory sensitivity in children with autism spectrum disorders. J Am Diet Assoc. 2010;110(2):238–246. Cutler AJ, Mattingly GW. Beyond the pill: new medication delivery options for ADHD. CNS Spectr. 2017;22(6):463–474. About Azurity Azurity Pharmaceuticals is a privately held global pharmaceutical company dedicated to addressing the critical and often invisible crisis facing overlooked patients by offering innovative solutions to meet their specific, unmet needs, which often are ignored by the broader biopharmaceutical industry and not typically addressed by generic manufacturers. By reformulating, adapting, and developing new therapies that meet specialized patient needs, we are delivering treatment alternatives that solve issues impacting patients’ day-to-day lives. Azurity has a broad portfolio of more than 50 medicines across 10 therapeutic areas fueling its mission, powered by a next generation AI-driven sales and marketing tool called Azurity Commercial Excellence (ACE) to optimize customer engagement and improve product delivery to overlooked patients. For more information, visit www.azurity.com. Media Contact media@azurity.com ©2026 Azurity Pharmaceuticals, Inc. All rights Reserved. This is intended for viewership in U.S. only. This press release may contain forward-looking statements subject to risks and uncertainties; actual results may differ materially. PP-ARY-7095-US-EN-v1 04/26