Woburn, MA, April 06, 2026 (GLOBE NEWSWIRE) — Azurity Prescription drugs, Inc. introduced that ARYNTA™ (lisdexamfetamine dimesylate) Oral Resolution is now to be had in the US for treating ADHD in adults and pediatric sufferers 6 years and older. Arynta, a ready-to-use lisdexamfetamine oral answer that can be saved at room temperature between 68°F to 77°F (20°C to twenty-five°C),1 gained 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,” mentioned Ronald Scarboro, CEO of Azurity Prescription drugs.
In pivotal Segment 3 medical trials that evaluated the efficacy and protection of lisdexamfetamine throughout pediatric and grownup affected person populations, lisdexamfetamine demonstrated statistically vital efficacy for the core signs of hyperactive-impulsive and inattention in ADHD.1 As a prodrug of amphetamine, Arynta delivers dependable symptom keep an eye on for as much as 13 hours in kids and as much as 14 hours in adults, and its protection and tolerability profile is very similar to that of alternative stimulant medicine.1-5
Please learn the overall Prescribing Data, together with Boxed Caution, and extra protection data at www.arynta.com.
Azurity Prescription drugs is dedicated to serving overpassed sufferers, together with those that have problem swallowing tablets or favor a liquid sort. It’s reported that roughly 70% of kids and about 30% of kids refuse or have problem swallowing drugs or tablets.6 Sure affected person populations are extra impacted than others. As an example, about 40% of kids with autism even have ADHD and lots of kids with autism fight with meals texture allergy, which can make taking medicine in pill and sprinkle sort a problem.7-10 Arynta is helping to handle this want as a part of Azurity’s cutting edge dose-form answers.
IMPORTANT SAFETY INFORMATION
ARYNTA™ (lisdexamfetamine dimesylate) Oral Resolution, CII
ARYNTA is a central frightened device (CNS) stimulant indicated for the remedy of:
Consideration Deficit Hyperactivity Dysfunction (ADHD) in adults and pediatric sufferers 6 years and older.Average to critical binge consuming dysfunction (BED) in adults.
Barriers of Use:
Pediatric sufferers with ADHD more youthful than 6 years of age skilled extra long-term weight reduction than sufferers 6 years and older.ARYNTA isn’t indicated or really helpful for weight reduction. Use of alternative sympathomimetic medication for weight reduction has been related to critical cardiovascular antagonistic occasions. The protection and effectiveness of ARYNTA for the remedy of weight problems have now not been established.
WARNING: ABUSE, MISUSE, AND ADDICTION
ARYNTA has a top possible for abuse and misuse, which may end up in the improvement of a substance use dysfunction, together with dependancy. Misuse and abuse of CNS stimulants, together with ARYNTA, may end up in overdose and loss of life [see Overdosage (10)], and this possibility is higher with upper doses or unapproved strategies of management, equivalent to snorting or injection.
Ahead of prescribing ARYNTA, assess every affected person’s possibility for abuse, misuse, and dependancy. Train sufferers and their households about those dangers, correct garage of the drug, and correct disposal of any unused drug. Right through ARYNTA remedy, re-examine every affected person’s possibility of abuse, misuse, and dependancy and incessantly observe for indicators and signs of abuse, misuse, and dependancy [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2)].
ADDITIONAL IMPORTANT SAFETY INFORMATION
Don’t take ARYNTA when you or your kid are:
Allergic to amphetamine merchandise or any of the elements in ARYNTA.Taking, or have stopped taking within the final 14 days, a medication known as Monoamine Oxidase Inhibitor (MAOI).Being handled with the antibiotic linezolid or intravenous methylene blue.
What are the conceivable unintended effects of ARYNTA?
ARYNTA would possibly motive critical unintended effects, together with:
Abuse, misuse, and dependancy: ARYNTA has a top probability for abuse and misuse and would possibly result in substance use issues, together with dependancy. Misuse and abuse of ARYNTA, different amphetamine containing drugs, and methylphenidate containing drugs, may end up in overdose and loss of life. The danger of overdose and loss of life is higher with upper doses of ARYNTA or when it’s utilized in ways in which don’t seem to be authorized, equivalent to snorting or injection. Your healthcare supplier must test you or your kid’s possibility for abuse, misuse, and dependancy earlier than beginning remedy with ARYNTA and can observe you or your kid all over remedy.ARYNTA would possibly result in bodily dependence after extended use, despite the fact that taken as directed via your healthcare supplier.Inform your healthcare supplier when you or your kid have ever abused or been depending on alcohol, prescription drugs, or side road medication. Dangers for other folks with critical middle illness: Unexpected loss of life has came about in individuals who have middle defects or different critical middle illness. Your supplier must test you or your kid moderately for middle issues earlier than beginning remedy with ARYNTA. Inform your healthcare supplier when you or your kid have any middle issues, middle illness, or middle defects. Greater blood drive and middle fee: Your healthcare supplier must test you or your kid’s blood drive and middle fee frequently all over remedy with ARYNTA. Psychological (psychiatric) issues: new or worse habits and idea problemsnew or worse bipolar illnessnew psychotic signs (equivalent to listening to voices, or seeing or believing issues that don’t seem to be actual) or new manic signs
Inform your healthcare supplier about any psychological issues you or your kid have or a few circle of relatives historical past of suicide, bipolar sickness, or melancholy.
Slowing of enlargement (peak and weight) in kids: Kids must have their peak and weight checked steadily all over remedy with ARYNTA. ARYNTA remedy could also be stopped in case your kid isn’t rising or gaining weight as anticipated.Movement issues in palms and feet (Peripheral Vasculopathy, together with Raynaud’s phenomenon): Indicators and signs would possibly come with: palms or feet would possibly really feel numb, cool, painfulfingers or feet would possibly alternate colour from light, to blue, to purple
Inform your healthcare supplier when you or your kid have numbness, ache, pores and skin colour alternate, or sensitivity to temperature to your palms or feet.
Serotonin Syndrome: A probably life-threatening downside known as serotonin syndrome would possibly occur when ARYNTA is interested by sure different drugs. Prevent taking ARYNTA and speak to your healthcare supplier or move to the closest sanatorium emergency room instantly when you or your kid increase any of the next indicators and signs of serotonin syndrome: speedy heartbeatseizuressweatingconfusiontremors, stiff muscle tissue, or muscle twitchingchanges in blood pressurenausea, vomiting, diarrhea seeing or listening to issues that don’t seem to be actual (hallucination) top frame temperature (hyperthermia) New or worsening tics or worsening Tourette’s syndrome: Inform your healthcare supplier when you or your kid get any new or worsening tics or worsening Tourette’s syndrome all over remedy with ARYNTA.
Ahead of taking ARYNTA, inform your physician about all of your scientific prerequisites, together with when you or your kid:
Have middle issues, middle illness, middle defects, or hypertension, or have a circle of relatives historical past of unexpected loss of life or middle rhythm problemsHave psychological issues together with psychosis, mania, bipolar sickness, or melancholy or have a circle of relatives historical past of suicide, bipolar sickness, or depressionHave move issues in palms and toesHave kidney problemsHave or had repeated actions or sounds (tics) or Tourette’s syndrome, or have a circle of relatives historical past of tics or Tourette’s syndromeAre pregnant or plan to turn into pregnant. ARYNTA would possibly hurt the unborn child. Inform your healthcare supplier when you turn into pregnant or assume you can be pregnant all over remedy with ARYNTA.Are breastfeeding or plan to breastfeed. ARYNTA passes into breast milk. You must now not breastfeed all over remedy with ARYNTA. Communicate on your healthcare supplier about one of the best ways to feed the infant all over remedy with ARYNTA.
Inform your healthcare supplier about all of the drugs that you simply or your kid take, together with:
Prescription and over the counter drugs, nutrients, and natural dietary supplements.ARYNTA can impact the way in which different drugs paintings and different drugs would possibly impact how ARYNTA works. Taking ARYNTA with different drugs could cause critical unintended effects. Now and again the doses of alternative drugs will want to be modified all over remedy with ARYNTA.
The commonest unintended effects of ARYNTA:
In kids 6 to 17 years and adults with ADHD come with lowered or lack of urge for food, diarrhea, dry mouth, bother napping, abdomen ache, nervousness, weight reduction, dizziness, irritability, nausea, and vomiting.In adults with BED come with dry mouth, lowered urge for food, constipation, nervousness, bother napping, higher middle fee, and feeling stressed.
The Necessary Protection Data does now not come with all of the data wanted to make use of ARYNTA safely and successfully. Please see accompanying complete Prescribing Data for ARYNTA.
To Document SUSPECTED ADVERSE REACTIONS, touch Azurity Prescription drugs, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
ARYNTA™ is a hallmark of Azurity Prescription drugs, Inc.
©2025 Azurity Prescription drugs, Inc.
PP-ARY-US-0003
References
Arynta [package insert]. Woburn, MA: Azurity Prescription drugs, Inc; 2025.Boellner SW, Stark JG, Krishnan S, Zhang Y. Pharmacokinetics of lisedexamfetamine dimesylate and its energetic metabolite, d-amphetamine, with expanding oral doses of lisdexamfetamine dimesylate in kids with attention-deficit/hyperactivity dysfunction: a single-dose, randomized, open-label, crossover find out about. Clin Ther. 2010;32(2):252-264Jasinski DR, Krishnan S. Abuse legal responsibility and protection of oral lisdexamfetamine dimesylate in folks with a historical past of stimulant abuse. J Psychopharmacol. 2009;23(4):419–427.Jasinski DR, Krishnan S. Human pharmacology of intravenous lisdexamfetamine dimesylate: abuse legal responsibility in grownup stimulant abusers. J Psychopharmacol. 2009;23(4):410–418.Kaland ME, Klein-Schwartz W. Comparability of lisdexamfetamine and dextroamphetamine exposures reported to U.S. poison facilities. Clin Toxicol (Phila). 2015;53(5):477–485.Polaha J, Dalton WT third, Lancaster BM. Parental file of medicine acceptance amongst early life: implications for on a regular basis follow. South Med J. 2008;101(11):1106-1112.Houghton R, Ong RC, Bolognani F. Psychiatric comorbidities and use of psychotropic medicines in other folks with autism spectrum dysfunction in the US. Autism Res. 2017;10(12):2037–2047.American Academy of Kid and Adolescent Psychiatry. ADHD in Formative years With ASD: Oldsters’ Medicine Information. Printed 2023. Accessed July 7, 2025. https://www.aacap.org/App_Themes/AACAP/doctors/resource_centers/sources/med_guides/ADHDwithASD_Web.pdfCermak SA, Curtin C, Bandini LG. Meals selectivity and sensory sensitivity in kids with autism spectrum issues. J Am Vitamin Assoc. 2010;110(2):238–246.Cutler AJ, Mattingly GW. Past the tablet: new medicine supply choices for ADHD. CNS Spectr. 2017;22(6):463–474.
About AzurityAzurity Prescription drugs is a privately held international pharmaceutical corporate devoted to addressing the essential and steadily invisible disaster going through overpassed sufferers via providing cutting edge answers to satisfy their particular, unmet wishes, which steadily are neglected via the wider biopharmaceutical trade and now not usually addressed via generic producers. By way of reformulating, adapting, and growing new remedies that meet specialised affected person wishes, we’re handing over remedy choices that clear up problems impacting sufferers’ day by day lives. Azurity has a huge portfolio of greater than 50 drugs throughout 10 healing spaces fueling its undertaking, powered via a subsequent era AI-driven gross sales and advertising and marketing instrument known as Azurity Business Excellence (ACE) to optimize buyer engagement and reinforce product supply to overpassed sufferers.
For more info, talk over with www.azurity.com.
©2026 Azurity Prescription drugs, Inc. All rights Reserved. That is meant for viewership in U.S. simplest. This press unlock would possibly include forward-looking statements matter to dangers and uncertainties; precise effects would possibly vary materially.
PP-ARY-7095-US-EN-v1 04/26
