Jazz Pharmaceuticals plc ( JAZZ Quick Quote JAZZ - Free Report) announced that it has enrolled the first patient in a phase II study evaluating its investigational candidate, JZP150, for the treatment of adult patients with post-traumatic stress disorder (“PTSD”), a psychiatric ailment.
The double-blind, randomized, placebo-controlled study will enroll 270 adults across the United States. The study will evaluate the safety and efficacy of two doses of JZP150 as once-daily treatment in adults aged between 18 to 70 years who are diagnosed with PTSD. The primary endpoint of the study measures participants' changes from the start of the study to the end of treatment using a score from the Clinician-Administered PTSD Scale.
Jazz expects to provide top-line data from this phase II study by 2023-end.
The FDA has already granted a Fast Track designation to JZP150 for the treatment of PTSD. If successfully developed and upon potential approval, JZP150 will become the first new drug to be approved for patients with PTSD in 20 years.
Shares of Jazz have declined 22.3% so far this year compared with the
industry’s 17% fall. Image Source: Zacks Investment Research
In October 2020, Jazz acquired a fatty acid amide hydrolase ("FAAH") inhibitor program, including JZP150, from SpringWorks Therapeutics. JZP150 is designed to address the underlying cause of PTSD as well as associated symptoms like anxiety, insomnia and nightmares.
Per the press release, currently approved medicines have limited efficacy and do not cure PTSD. Hence, if successfully developed and upon potential approval, JZP150 can serve an area of high unmet medical need and treat this debilitating disorder.
Jazz’s neuroscience franchise — which consists of three sleep disorder drugs (Xyrem, Sunosi, and Xywav) and one seizure drug (Epidiolex) — is a key revenue generator for the company. The marketed neuroscience drugs generated revenues of $646.1 million in third-quarter 2021. Meanwhile, Jazz continues to boost this franchise through acquisitions or partnerships. In May 2021, Jazz acquired a British cannabinoid drug company, GW Pharmaceuticals. The acquisition added Epidiolex — approved for the treatment of seizures associated with two rare and severe forms of epilepsy, namely Lennox-Gastaut syndrome and Dravet syndrome — to its portfolio.
Zacks Rank & Stocks to Consider
Jazz currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include
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