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Details:
Tris Pharma and Perigon launched a direct-to-patient program, that allows patients and caregivers access to DYANAVEL XR (amphetamine) extended-release tablets through Perigon’s digital pharmacy and receive assistance and support to help navigate their treatment journey.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: Dyanavel XR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Perigon Pharmacy 360
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 30, 2023
Details:
Under the agreement, Aardvark will acquire certain assets and intellectual property of the Company that pertain to ADAIR, a proprietary abuse-deterrent formulation of immediate release dextroamphetamine, for the development of certain follow-on pipeline programs.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aardvark Therapeutics
Deal Size: $80.0 million Upfront Cash: Undisclosed
Deal Type: Agreement August 23, 2023
Details:
Under the agreement, Medomie will commercialize Adzenys XR-ODT (amphetamine) and Cotempla XR-ODT (methylphenidate) in Israel and the Palestinian Authority.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: Adzenys XR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aytu BioPharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 31, 2023
Details:
Under the agreement, Glenmark will distribute Cediprof's FDA approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), the generic version of Adderall® Tablets.
Lead Product(s): Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: Adderall-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cediprof
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 09, 2023
Details:
Dextroamphetamine Sulfate is a non-catecholamine sympathomimetic amines with CNS stimulant activity. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Lead Product(s): Amphetamine,Dextroamphetamine Saccharate,Amphetamine Aspartate
Therapeutic Area: Psychiatry/Psychology Product Name: Amphetamine-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2023
Details:
Xelstrym™ (dextroamphetamine) is a first and only FDA-approved, once-daily central nervous system stimulant transdermal patch for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: Xelstrym
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2023
Details:
Dyanavel XR oral suspension (amphetamine) is a CNS stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control used for the treatment of attention deficit hyperactivity disorder (ADHD) in people 6 years and older.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: Dyanavel XR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pediatrix Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership December 01, 2022
Details:
XELSTRYM is the first and only FDA-approved, once-daily amphetamine transdermal patch for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: Xelstrym
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 17, 2022
Details:
XELSTRYM is the first and only FDA-approved, once-daily amphetamine transdermal patch for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: Xelstrym
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2022
Details:
XR-ODT is FDA-Approved as Bioequivalent to Adderall XR is the only FDA-approved, extended-release, orally-disintegrating tablet formulation of amphetamine,indicated for the treatment of ADHD in patients six years and older.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: Adzenys XR-ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2022
Details:
DYANAVEL XR is a central nervous system stimulant prescription medicine used for the treatment of ADHD in people 6 years and older. DYANAVEL XR (amphetamine) may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: Dyanavel XR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2022
Details:
Pharmacokinetic analysis showed that ADAIR (dextroamphetamine) intranasally demonstrated blunted pharmacokinetic profile compared to crushed and snorted dextroamphetamine including Cmax,Tmax, and AUC, especially during early time points up to 1, 2, and 4 hours after dosing.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
ADAIR (dextroamphetamine), investigational new drug; a novel, patented formulation designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high".
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2022
Details:
Study did not meet primary endpoint of significant reduction in Emax Drug Liking for ADAIR (dextroamphetamine) vs reference dextroamphetamine, although a trend in favor of ADAIR was observed (p=0.16).
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Details:
Results from the study, entitled “A Randomized, Double-Blind, Placebo-Controlled, Crossover, Laboratory Classroom Study to Evaluate the Safety and Efficacy of d-Amphetamine Transdermal Drug Delivery System,” will be presented at the APA Annual Meeting.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ATS
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2021
Details:
ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a novel, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.”
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2021
Details:
Noven’s Dextroamphetamine, in 4.5mg/9 hours, 9.0 mg/9 hours, 13.5mg/9 hours and 18.0mg/9 hours dosage strengths, is an investigational therapy developed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) for patients six years and older.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2021
Details:
Results from the study, “Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of the Amphetamine Extended-Release Tablet in Adults with Attention-Deficit/Hyperactivity Disorder,” were reported during the annual APSARD meeting.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: TRN-110
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2021
Details:
Results demonstrated that ADAIR had slower absorption and lower early exposure, and was less desirable to recreational drug abusers on key measures of abuse liability compared to commercially available dextroamphetamine.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
The company's clinical-stage product currently under development is Abuse-Deterrent Amphetamine Immediate-Release, or ADAIR. ADAIR has completed a Phase 1 pivotal bioequivalence study and a Phase 1 food effect study.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering October 23, 2020
Details:
The new amphetamine extended-release tablet is an investigational agent and is not currently approved for use in any country.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: TRN-110
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
The Phase 3 data being presented support Arbor’s New Drug Application (NDA) for AR19, which also includes data demonstrating that AR19 resists manipulation for nonmedical misuse and abuse by non-oral routes of administration.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: AR19
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Details:
If approved, AR19 would be the first-ever FDA-approved ADHD stimulant medication designed to resist manipulation for nonmedical use, which may help to deter misuse and abuse by intranasal, intravenous and smoking routes of administration.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
Company to begin enrolling phase 1 clinical trial for first immune tolerance product, KAN-101, in first quarter of 2020.
Lead Product(s): Amphetamine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 2020
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