Praxis Bioresearch Awarded $1.5 Million Fast-Track SBIR Grant for Development of Novel Prodrug Stimulant with Abuse-Deterrent Properties

National Institutes of Health Funding to Support Ongoing Advancement of Innovative Stimulant Therapy Designed with Significantly Reduced Risk of Abuse

MENLO PARK, Calif., Aug. 07, 2018 (GLOBE NEWSWIRE) -- Praxis Bioresearch, a biopharmaceutical company focused on the discovery and development of novel therapeutics for chronic neuropsychiatric and neurodegenerative disorders, today announced that it has been awarded a Fast-Track Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The $1.5 million award will support the ongoing development of the company’s lead product candidate, PRX-P4-003, a prodrug stimulant with abuse deterrent properties. 

PRX-­P4-­003 is a novel, abuse-deterrent dopamine norepinephrine reuptake inhibitor incorporating an active isomer of fencamfamine (FCF), a well-tolerated Schedule IV stimulant.  Fencamfamine has a long-established clinical profile following decades of therapeutic use in Europe and other countries, where it was primarily prescribed for depressive daytime fatigue, lack of concentration, and lethargy.

Unlike other stimulants, prodrug PRX-­P4-­003 is specifically designed to produce therapeutic stimulant activity when delivered orally but lack any such activity if illicitly injected for euphoric reasons. This is made possible due to PRX-P4-003 serving as a substrate of pancreatic lipase, an enzyme whose biological activity is almost entirely restricted to the gut.  Intact prodrug PRX-P4-003 lacks any stimulant activity until it is enzymatically metabolized to release the fencamfamine isomer. Translated into humans, this profile may discourage abuse and diversion while providing effective stimulant treatment by the oral route.  Additionally, the prodrug’s inherently delayed activation in the gut until it reaches the small intestine provides an added protective mechanism, minimizing the potential for its oral abuse.

Data that were presented at the 2017 annual meeting of the American College of Neuropsychopharmacology and published in the journal Drug and Alcohol Dependence demonstrated that orally dosed prodrug PRX-P4-003 possessed the established biological activity of stimulants, while pharmacokinetically limiting the potential for IV abuse in preclinical models.  Praxis is initially developing the prodrug for the treatment of binge eating disorder, an underserved medical need which represents the most common eating disorder and affects millions of adults in US.  The company also believes the drug candidate has potential in the treatment of apathy in Alzheimer’s disease patients and plans to further study the compound in that indication as well.

“There is a clear and urgent need for safer approaches to commonly prescribed pharmaceuticals that are prone to abuse.  We believe that PRX-P4-003 may offer an innovative solution in providing patients the benefits of proven therapeutic stimulant activity with a significantly reduced risk of abuse,” said Sandeep Patil, PhD, MD, chief executive officer of Praxis Bioresearch. “We are pleased to receive this highly competitive SBIR award as we work diligently to build upon our promising preclinical data. The funding will support continued advancement of PRX-P4-003.”

Stimulants such as methylphenidate and amphetamines are among the most widely prescribed classes of medications, with an estimated 90 million annual prescriptions written for a range of central nervous system conditions including attention deficit hyperactivity disorder (ADHD) and binge eating disorder. According to a report issued by Persistence Market Research, the stimulant market for ADHD alone is expected to grow to $25 billion annually in 2024. However, stimulants are classified as Schedule II controlled drugs due to a significantly high risk of addiction. Accordingly, there is a significant unmet need for effective abuse-deterrent stimulant formulations.

Manufacturing services supporting Praxis’ ongoing development of PRX-P4-003 are being provided by Alchem Laboratories.

About Praxis Bioresearch

Praxis Bioresearch, LLC, is a biopharmaceutical company focused on the discovery and development of therapeutics for chronic neuropsychiatric and neurodegenerative disorders. Praxis’ lead development candidate is PRX-P4-003, a novel prodrug stimulant designed to offer the proven clinical activity of currently marketed stimulants while reducing risk of abuse and addiction.  PRX-P4-003 is being developed for the treatment of binge eating disorder and apathy in Alzheimer’s Disease. For more information visit:

Disclaimer: The SBIR Grant (R44MH116764) is supported by the NIMH, NIH. The content of this press release is solely the responsibility of Praxis Bioresearch and does not necessarily represent the official views of the NIH.



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