Pain is the number one reason most Americans go to the doctor is pain, says Cindy Steinberg, Director of Policy and Advocacy for the U.S. Pain Foundation, in the latest episode of the I am BIO podcast.
Yet, according to the experts, regulations, and policies keep R&D for new pain medications at a standstill.
According to Biotechnology Innovation Organization (BIO) CEO Rachel King, at least 50 million people in the U.S. experience pain daily. In addition, chronic pain is “the number one reason for disability,” adds Steinberg.
Due to their highly addicting nature, opioids are becoming a thing of the past. New pain drugs are needed to replace them, but since 2017, we’ve seen a “44% reduction in the number of pain drugs in the pipeline,” says David Thomas, BIO’s V.P. of Industry Research, co-author of BIO’s new report on the pain and addiction pipeline.
“Our findings here are perhaps the worst we’ve ever seen,” Thomas said. “What we found is that as companies go into their first Phase 1 trial for pain medication, they have less than a one in 100 chance in making it to FDA approval—it’s 0.7% to be exact.”
According to Thomas, the drug price controls in the Inflation Reduction Act (IRA) offer extended price protection to big-molecule biologics. This could deter the development of small-molecule drugs. The problem is that pain medications typically consist of small molecules because they must penetrate the blood-brain barrier.
As another barrier, the U.S. Food and Drug Administration (FDA) must identify biomarkers for expedited drug development, added Thomas.
New pain medications in the pipeline
“There are also solutions that BIO advocates for on the regulatory front, and that is, for example, to have clear definitions of how to achieve an expedited development pathway through the FDA to help identify new biomarkers that can be used in clinical trials and how to potentially run innovative clinical trial designs, and maybe use real-world evidence, patient-reported outcomes data for those trials. So those are some of the things that can help on the regulatory front,” Thomas explains.
Nonetheless, there have been exciting developments in the pain pipeline.
According to Senior Vice President Paul Negulescu, Vertex is creating a strategy unlike anti-inflammatories or opioids. This strategy is based on decades of expensive research into the sodium channel of sensory nerves.
South Rampart Pharma is developing pain medications with a mechanism comparable to acetaminophen in Tylenol, says CEO Hernan Bazan. The difference is that their drug does not have side effects on the liver or kidneys.
“We need more breakthroughs in the pain pipeline. BIO’s report shows that investment in pain and addiction remains disproportionate to the gravity of the societal problem,” King concludes. We need improved regulation and “continued commitment by researchers, advocates, and drug developers like our guests.”
How to listen to the I am BIO Podcast: The new season of the I am BIO Podcast is available via Apple, Google, Spotify, or wherever you get your podcasts, with new episodes released every other Tuesday.