Sen-Jam Pharmaceutical, based in New York, has commenced a Phase II clinical trial in Australia to assess the efficacy of SJP-001 in preventing hangovers. The company aims to develop the first FDA-approved hangover prevention therapy, addressing a significant unmet need in managing alcohol-related symptoms.
SJP-001: A Novel Approach to Hangover Prevention
SJP-001 is a combination drug containing naproxen, a nonsteroidal anti-inflammatory drug (NSAID), and fexofenadine, an antihistamine. The formulation is designed to mitigate the inflammatory response triggered by alcohol consumption, which is believed to be the primary cause of hangover symptoms. Pre-clinical studies have shown promising results in reducing the severity and duration of these symptoms.
Jackie Iversen, co-founder and chief clinical officer at Sen-Jam Pharmaceutical, stated, "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."
Prior Clinical Evidence
Sen-Jam Pharmaceutical previously obtained an FDA Investigational New Drug Application (IND) to initiate Phase I and II clinical trials. This decision was supported by a pilot study published in the Journal of Clinical Medicine in 2020, which indicated that SJP-001 significantly reduced hangover severity compared to placebo. The study specifically noted improvements in symptoms such as thirst, headache, dizziness, and nausea.
Innovative Funding Model
The Phase II trial is notable for its funding approach, which includes crowdfunding and the sale of fractional royalty rights in the product and the company's patent portfolio. This strategy allows the company to engage directly with investors and potentially return capital soon after licensing deals are secured.
Jim Iversen, CEO of Sen-Jam Pharmaceutical, commented, "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."
Regulatory Landscape and Market Potential
Sen-Jam has secured formulation patents for its hangover preventative in the US, Europe, Australia, Japan, Mexico, and South Africa. The company aims to establish SJP-001 as the only over-the-counter hangover preventative backed by regulatory approval.
Economic Burden of Excessive Alcohol Consumption
According to research by the US Center for Disease Control, excessive drinking cost the United States approximately $249 billion in 2010. This translates to an additional $2.05 in economic costs for every alcoholic drink consumed, highlighting the significant economic impact of alcohol-related issues.
Broader Context: Alcohol Use Disorder Treatments
Other companies are also developing treatments for alcohol-related issues. Imbrium Therapeutics recently submitted an IND for a Phase II clinical trial of Sunobinop for moderate to severe alcohol use disorder (AUD). Additionally, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) awarded a $2 million grant to Amygdala Neurosciences to support an IND for an aldehyde dehydrogenase (ALDH2) inhibitor for AUD treatment.
