Jazz Pharmaceuticals Begins Enrollment For Clinical Trial To Evaluate JZP150 For Adults With PTSD

Biopharmaceutical company Jazz Pharmaceuticals plc JAZZ announced Thursday that it has enrolled the first patient in its Phase 2 clinical trial evaluating the safety and efficacy of JZP150, an investigational first-in-class small molecule for the treatment of adults with post-traumatic stress disorder.

JZP150 is designed to address the underlying cause of PTSD and patients' associated symptoms such as anxiety, insomnia and nightmares.

An investigational small molecule, JZP150 is formulated to selectively inhibit the enzyme fatty acid amide hydrolase and is currently in development to treat PTSD in adults.

In addition, JZP150 was granted Fast Track designation by the U.S. Food and Drug Administration, a status granted with the intention to facilitate the development and expedite the review of medicines that treat serious conditions and have the potential to address unmet medical needs.

"FDA's Fast Track designation of JZP150 is a notable recognition of both the serious, ongoing, unmet medical needs of PTSD patients and the potential benefits of JZP150's novel mechanism to treat this debilitating disorder," said  Dr. Rob Iannone, M.D., M.S.C.E., chief medical officer and executive VP of research and development at Jazz Pharmaceuticals. "The disease burden for PTSD can have a devastating impact on patients and their families for this common condition where the prevalence is expected to increase."

Jazz acquired worldwide rights to JZP150, formerly called PF-04457845, from SpringWorks Therapeutics in October 2020. The molecule was initially discovered and developed by Pfizer Inc. PFE.

Phase 2 Trial Details

The Dublin-based company said the trial would enroll 270 adults aged 18 to 70 diagnosed with PTSD.

The multicenter, double-blind, randomized, placebo-controlled clinical trial will evaluate two doses of JZP150 and is being conducted across 40 U.S. study sites.

"JZP150 targets a novel mechanism in the brain, and this new Phase 2 trial in PTSD will help us to learn more about the molecule's safety and effectiveness as a potential treatment for patients who would benefit from a novel therapy," explained John H. Krystal, M.D., the Robert L. McNeil Jr. professor of translational research and professor of psychiatry, neuroscience, and psychology at Yale University.

Jazz Pharmaceuticals & CBD

Earlier this year, Jazz Pharmaceuticals purchased GW Pharmaceuticals plc., producer of FDA‑approved prescription cannabidiol drug Epidiolex for $7.2 billion or $6.7 billion net of GW Pharma's cash.

The acquisition brought Epidiolex — a cannabidiol oral solution approved for patients one year and older to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex — into Jazz's portfolio.

More Recent News From Jazz Pharmaceuticals:

• Jazz Pharmaceuticals Reports Q3 Financial Results, Raises Full-Year Earnings Guidance
• Jazz Pharmaceuticals Q2 Revenue Jumps 34% To $751.8M With $109.5M Epidiolex Net Sales, Reaffirms Its 2021 Guidance Of $3.02B

JAZZ Price Action

Jazz Pharmaceuticals' shares traded 0.50% lower at $130.87 per share at the time of writing on Thursday.

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