Sen-Jam’s First-in-Class FDA-Regulated Hangover Cure Enters Phase 2 Trials

New York-based Sen-Jam Pharmaceutical has launched a Phase 2 clinical trial for its hangover prevention therapy, SJP-001. The trial, conducted in Australia, aims to evaluate the compound’s potential as the first U.S. Food and Drug Administration (FDA)-approved treatment for hangover prevention. SJP-001 combines naproxen and fexofenadine, designed to reduce inflammation caused by alcohol consumption. This milestone trial addresses a global health issue, offering a potential solution to alcohol-related productivity losses.

Over 960 Investors Back Innovative Pharma Model with Crowdfunding and Fractional Royalty Rights

SJP-001, backed by Sen-Jam’s portfolio of 23 patents, marks a shift in both understanding and treating alcohol hangover symptoms. Essentially, the therapy targets the inflammatory response triggered by alcohol, offering an alternative to hydration and other less effective methods.

This trial is made possible by Sen-Jam’s innovative funding model. By utilizing crowdfunding and selling Fractional Royalty Rights (FRR) on its patents, the company has opened pharmaceutical investment to the public. Over 960 investors have supported the initiative, with 24% reinvesting, reflecting strong belief in SJP-001’s potential. This unique funding strategy enables Sen-Jam to remain agile while delivering safe, effective therapeutics. It also empowers a global network of supporters to share in the company’s success.

“Our FRR offering allows everyday people to directly support innovation while creating an opportunity for financial returns,” said Jim Iversen, CEO of Sen-Jam Pharmaceutical. “It also enables us to return capital to our investors soon after licensing deals are in place.”

The company has obtained formulation patents for SJP-001 in the US, Europe, Australia, Japan, Mexico, and South Africa. It aims to position SJP-001 as the first over-the-counter hangover preventative with genuine regulatory approval.

Targeting Inflammation to Boost Health and Productivity for Moderate Drinkers

SJP-001 targets inflammation to protect cells and tissues from alcohol-related damage, supporting health and productivity. The therapy aligns with efforts to enhance resilience and well-being for moderate drinkers. “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,” explained Iversen. This approach positions SJP-001 as a tool to improve lives while addressing alcohol’s effects.

“Pre-clinical studies of SJP-001 have shown great promise in reducing both the severity and duration of morning-after symptoms,” said Jackie Iversen, Co-Founder and Chief Clinical Officer. “Our approach is based on international research identifying inflammation as the primary driver of these alcohol-related symptoms.”

Sen-Jam Targets $217 Billion Market with Innovative Solutions for Arthritis, Opioid Withdrawal, COVID-19, and More

Besides hangover cures, Sen-Jam Pharmaceuticals is developing a portfolio of anti-inflammatory drugs targeting multiple high-value sectors within the healthcare industry. The company is focusing on addressing unmet needs in several multi-billion-dollar markets that have seen limited innovation over the past few decades. These sectors include arthritis, opioid withdrawal, viral respiratory infections, COVID-19 therapeutics, vaccine administration, and alcohol hangovers, with a total addressable market (TAM) estimated at $217 billion.

A large part of the market focuses on arthritis treatments for both acute and chronic conditions. Sen-Jam is also targeting the opioid crisis by exploring solutions for opioid withdrawal. This area urgently needs safe, non-addictive therapies, as the demand for effective treatments in chronic pain grows. Here, the negative impact of opioid dependence remains a critical area of focus, making it difficult to open the door on these kinds of treatments. 

In addition, Sen-Jam is expanding its focus to include viral respiratory infections. The company’s oral anti-inflammatory drug for COVID-19 aims to manage inflammation caused by these infections. Additionally, Sen-Jam is exploring how its therapies could help with vaccine administration. This includes targeting immune responses that can cause unwanted inflammation after vaccination. Through this broad approach, Sen-Jam is tackling significant gaps in several healthcare sectors.

Sen-Jam Accelerates Drug Development with Small Molecules and the 505(B)2 Pathway

The company’s approach includes developing a range of products with varying routes of administration—some for over-the-counter (OTC) use, some for prescription (Rx), and others for injectable use in urgent care settings. This broad product strategy allows the Sen-Jam to tap into various healthcare segments and address both preventive and therapeutic needs, to attempt leveraging the widespread market potential.

With a focus on repurposing small molecules which they claim are backed by over 30 years of safety data, Sen-Jam plans to fast-track its drug development through the FDA’s 505(B)2 regulatory pathway, accelerating the time to market. The company’s international patent portfolio supports its global commercialization efforts, positioning it to expand into key markets such as the US, Europe and Asia.

The anti-inflammatory market as a whole is valued in the trillions, making it one of the most lucrative segments in pharmaceuticals. Sen-Jam’s ability to enter and disrupt this space, particularly with its novel approach to inflammation through mast cell modulators, positions it to potentially capture a significant share of this vast market. The company’s innovative, safe, and fast-acting drugs, which target the root causes of inflammation, could reshape treatment options in these high-growth sectors.

Author

Bernice Lottering