With nearly all experimental pain and addiction drugs failing to make it out of the clinic over the past five years, it’s not hard to see why pharma has been resistant to drug development in this area. A new report from the Biotechnology Innovation Organization (BIO) catalogs the dearth of investment in new nonaddictive drugs to relieve pain and addiction despite an obvious unmet need.
The number of clinical trial programs underway for pain drugs dropped 44% from 220 in 2017 to 124 in 2022, according to the BIO report released Thursday. Drugs that do make it to the clinic face overwhelming odds. Just 0.7% of new pain drugs progressed from phase 1 through to approval. This compares to an overall rate of 6.5% for therapies across all disease areas.
One shining spot in the pain market has been migraine headaches, where advancements in science have led to the approval of several innovative medicines in recent years. Other than that, BIO said there have been no additional approvals of nonaddictive novel targeting drugs to address chronic pain conditions in the past five years.
The same can be said for medicines to address addiction, although the situation is even more stark for that indication. While the number of therapies rose from 29 in 2017 to 39 now, the phase 2 failure rate was 93% over the past five years. Adial Pharmaceuticals reported the phase 3 failure of AD04 in alcohol addiction last year.
And for both pain and addiction, most of the therapies in the pipeline tackle already-known targets, meaning there’s not a lot of innovation going on or fresh ideas coming down the pike.
“With more than 100 million Americans currently living with pain or addiction, it was troubling to find the clinical pipeline for pain deteriorating and a scarcity of late-stage addiction programs,” said David Thomas, senior vice president of industry research and analysis at BIO.
One major problem is the lack of private investment, which is not matching the magnitude of the problem in society, the authors said. Just 1.3% of venture capital dollars, or $228 million, went to pain- and addiction-focused companies in 2021. Meanwhile, oncology companies raised $9.7 billion.
“Addressing this unmet need will require greater public and private investment. Rebuilding the pain and addiction innovation landscape could save thousands of American lives while improving millions more,” said Rachel King, interim CEO at BIO.
BIO recommends a strong regulatory and policy environment to spur companies to develop new pain and addiction meds. Policy decisions of late still encourage prescribing and covering therapies that are less safe and less effective. Without change, investment will not flow in.
One therapy making waves in the clinic is Vertex’s VX-548, which was cleared to advance into phase 3 trials this past summer after success in a midstage trial. Compared to placebo, VX-548 offered rapid relief of pain intensity over 48 hours after bunion removal or tummy-tuck surgery. The therapy is a selective NaV1.8 inhibitor, and the NaV1.8 pathway plays a role in pain signaling in the peripheral nervous system.
By Annalee ArmstrongFeb 2, 2023 06:00am