amphetamine sulfate immediate release (AR19) / Azurity Pharma - LARVOL DELTA

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AR19, a Manipulation-Resistant Formulation of Amphetamine Sulfate, in Adults With Attention-Deficit/Hyperactivity Disorder. (PubMed, J Clin Psychiatry) - P3 | " AR19 demonstrated efficacy on all endpoints and was generally well tolerated, supporting the efficacy and safety of AR19 20 mg and 40 mg in adults with ADHD. Trial Registration: ClinicalTrials.gov Identifier: NCT03659929."

Clinical • Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Cardiovascular • CNS Disorders • Insomnia • Pain • Psychiatry • Sleep Disorder • Xerostomia

Countercurrent chromatographic fractionation followed by gas chromatography/mass spectrometry identification of alkylresorcinols in rye. (PubMed, Anal Bioanal Chem) - "Novel or rarely reported ARs were detected in virtually all classes, i.e. saturated AR (AR14:0), even-numbered monounsaturated AR isomers (AR16:1-AR26:1), triunsaturated ARs (AR25:3), oxo-ARs (AR17:0 oxo, AR19:1 oxo, AR21:2 oxo, AR23:2 oxo) and odd-numbered methyl-ARs (mAR15:0-mAR23:0). Positions of the double bonds of monounsaturated ARs and oxo-ARs were determined with the help of dimethyl disulfide (DMDS) derivatives. Graphical abstract."

Journal

[VIRTUAL] Abuse Potential of Manipulated Amphetamine Sulfate (AR19) When Administered Intranasally to Nondependent Recreational Stimulant Users (AACAP 2020) - No abstract available

Arbor Pharmaceuticals announces FDA filing acceptance of New Drug Application (NDA) for AR19, an investigational ADHD prescription stimulant treatment specifically designed to resist physical manipulation for nonmedical misuse or abuse (PRNewswire) - "Arbor Pharmaceuticals, LLC,...announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for AR19, an investigational immediate-release, amphetamine capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children 3-17 years of age and in adults 18 and older...The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2020."

NDA • PDUFA date • Attention Deficit Hyperactivity Disorder • CNS Disorders

Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate (clinicaltrials.gov) - P3; N=320; Completed; Sponsor: Arbor Pharmaceuticals, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Sep 2019 ➔ Apr 2019

Clinical • Trial completion • Trial completion date

Pharmacokinetics of AR19, an Immediate-Release Amphetamine Sulfate Formulation Designed to Deter Manipulation for Administration Via Nonoral Routes: Bioequivalence to Reference Racemic Amphetamine Sulfate, Dose Proportionality, and Food Effect. (PubMed, J Child Adolesc Psychopharmacol) - "Bioavailability was similar at doses between 5 and 30 mg and was not impacted by meal consumption or sprinkling on food. AR19 at tested doses was well tolerated."

Journal • PK/PD data

Granules India receives USFDA approval for amphetamine sulfate tablets (Business Standard) - "Granules India announced that USFDA has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc., a wholly owned foreign subsidiary of Granules India Limited for Amphetamine Sulfate Tablets USP 5 mg and 10 mg....Used to treat sleep disorder, increase attention, decrease impulsiveness and hyperactivity in patients with Attention Deficit Hyperactivity Disorder (ADHD)."

ANDA

Bioavailability of Manipulation-Resistant, Immediate-Release Amphetamine (AR19) in Adults: Influence of Food on Intact Capsule or Sprinkled Pellets (APA 2019) - "The high-fat/-calorie meal with AR19 capsule increased Tmax of d- and l-AMP, though had no effect on Cmax, indicating delayed absorption but similar exposure vs fasting. Overall, there were no significant alterations in d- and l-AMP bioavailability with high-fat/-calorie meal or sprinkled pellets on food. AR19 (20 mg) was well tolerated by healthy volunteers."

Clinical

81 Bioequivalence of a Manipulation-Resistant Immediate-Release Amphetamine Sulfate Formulation Compared with Reference Standard. (PubMed, CNS Spectr) - "AR19 was well tolerated and was bioequivalent to reference when administered as a 20-mg dose in healthy volunteers.Funding Acknowledgements: This study was funded by Arbor Pharmaceuticals, LLC."

Journal

Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate (clinicaltrials.gov) - P3; N=312; Active, not recruiting; Sponsor: Arbor Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed