Biotech Bulletin: In Pursuit of Pain Management
More than 50 million Americans are living with daily pain that significantly impacts their ability to work and participate in daily activities. The cost to the US economy exceeds $635 billion in medical treatment and lost productivity each year.
There is a dearth of effective non-opioid treatments to manage that pain, and according to the National Institutes for Health (NIH) Pain Consortium, the United States is facing a double crisis: opioid addiction and unrelieved pain.
Opioid Use Disorder (OUD) affects over 2.1 million Americans, and more than 16 million people worldwide. The US Department of Health and Human Services (HHS) officially declared opioid abuse a public health emergency in 2017, highlighting the significant unmet medical need for new, safe, and effective treatments.
Drug development in the pain management space is complex and fraught with potential failure, but the opportunity is attractive for pharmaceutical companies that succeed. The global pain management drugs market size reached $78.41 billion in 2022 and is projected to reach around $115.50 billion by 2032.
A number of biotechs are working towards developing treatments that provide patients with meaningful pain relief for acute and chronic pain:
Vertex Pharmaceuticals (Nasdaq: VRTX)
In January, Vertex announced positive results from its Phase 3 program for the selective NaV1.8 inhibitor, VX-548, in the treatment of moderate-to-severe acute pain. Treatment with VX-548 led to statistically significant improvement in pain compared to placebo and was effective in reducing pain in a broad range of surgical and non-surgical pain conditions for up to 14 days. It was also found to be safe and well tolerated. Vertex has been granted FDA Breakthrough and Fast Track Designations for VX-548 and plans to submit a New Drug Application to the FDA by mid-2024.
Ensysce is using its proprietary technology platforms to develop safer treatment options for pain that minimize the risk of both drug abuse and overdose. In December, Ensysce announced key efficacy data for its lead analgesic candidate, PF614, reinforcing its efficacy as a next generation analgesic with significant pain intensity reduction. The company stated that it believes PF614 to be the first abuse-protective opioid and a potential revolutionary treatment for severe pain. Ensysce expects to meet with the FDA for an End of Phase 2 meeting scheduled in late January. PF614 has been fast tracked by the FDA.
Virpax Pharmaceuticals (Nasdaq: VRPX)
Virpax (Nasdaq: VRPX) is developing non-addictive products for pain management. Its lead candidate for pain relief is Probudur, which is being developed to significantly reduce or eliminate the need for opioids after surgery or trauma in approved indications. In pre-clinical trials, Probudur has shown long duration pain control for at least 96 hours. Virpax is on target to file its Investigational New Drug (IND) Application for Probudur in the second half of 2024.
Continued collaboration between pharmaceutical companies, academic institutions, and public organizations will help advance research and spur investment in pain management to expedite the development of effective pain therapies.