New York-based company, Sen-Jam Pharmaceutical, is initiating a Phase II trial examining its hangover prevention therapy SJP-001.
According to the company the compound could potentially be the world’s first US Food and Drug Administration (FDA) approved hangover prevention therapy.
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Sen-Jamhas said trials of the novel hangover prevention remedy will begin in Australia, comprising a combination of naproxen and fexofenadine, designed to reduce the inflammatory response after alcohol consumption that typically manifests as a hangover.
Previously the company was able to obtain an FDA Investigational New Drug Application (IND) to begin phase I and II clinical trials after pilot study research published in 2020 in the Journal of Clinical Medicine found SJP-001 was able to mitigate symptoms such as thirst, headache, dizziness, or nausea. The same study concluded that SJP-001 was significantly more effective in reducing hangover severity than placebo.
Jackie Iversen, co-founder and chief clinical officer at Sen-Jam Pharmaceutical, said: “Pre-clinical studies of SJP-001 have demonstrated remarkable promise in reducing both the severity and duration of morning-after symptoms.
“Our approach is grounded in cutting-edge international research that has identified inflammation as the primary driver of these alcohol-related symptoms.”
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By GlobalDataThe Phase II trial is somewhat unique in as much as it is partially crowdfunded as well as financed through the sale of fractional royalty rights in the as-yet-unnamed product and the rest of the company’s patent portfolio.
So far, the company has secured formulation patents for the hangover preventative in the US, Europe, Australia, Japan, Mexico, & South Africa, with the company hoping to establish SJP-001 as the only over-the-counter hangover preventative to be backed by genuine regulatory approval.
Jim Iversen, CEO of Sen-Jam Pharmaceutical, said: “Our fractional royalty rights offering allows everyday people to directly support innovation while creating an opportunity for financial returns. It also enables us to return capital to our investors soon after licensing deals are in place.
“This innovative solution is about promoting human health and maximizing productivity by supporting individuals who choose to consume moderate levels of alcohol. Our focus is on enhancing well-being, fostering resilience, and empowering people to thrive in both personal and professional spheres.”
Research conducted by the US Center for Disease Control estimates that excessive drinking cost the United States about $249 billion in 2010, with every alcoholic drink consumed creating an extra $2.05 in economic costs to address alcohol-related impacts.
Elsewhere in the world of alcohol treatment, Imbrium Therapeutics has announced the submission of its own IND for a Phase II clinical trial of Sunobinop to potentially treat moderate to severe alcohol use disorder (AUD). Meanwhile, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) has awarded a $2m grant to Amygdala Neurosciences to support another IND for an aldehyde dehydrogenase (ALDH2) inhibitor for the treatment of alcohol use disorder.
