[Updated 2/12/2018, 1:37pm ET, see below.] With the opioid epidemic showing little sign of letting up, new ways of treating chronic pain are desperately needed. But the development of non-addictive, non-opioid pain drugs lags far behind drug R&D for other diseases (I wrote a few months ago about why that is), and a report from BIO released today helps quantify just how little the industry is doing in this area, and how rarely they succeed when companies do try. The report comes out on the same day that the White House released its 2019 budget, which includes billions of dollars to tackle the opioid crisis.
Some key points from the BIO report:
- Pain drug developers have managed a meager 2 percent chance of gaining FDA approval for novel drugs, if they make it to phase 1. Across all other disease areas, that success rate is 10 percent.
- FDA has approved only two new chemical entities for pain in the last 10 years.
- There are 220 clinical stage drugs in the pain pipeline across the industry, with 125 of them being novel chemical entities. For comparison’s sake, the oncology pipeline is bursting with 2,617 drug programs.
- Only 15 clinical programs are testing new compounds for addiction treatment.
The number of current clinical-stage pain drugs in the pipeline isn’t enough, said report co-author David Thomas, BIO’s senior director of industry research and policy analysis. “As some of these future successes may be specific for chronic migraine and indications where opioids are not prescribed, more shots on goal are needed to fill the void in chronic pain,” said Thomas in a statement.
The report only briefly touches on some broad ways to boost pain drug development, such as coming up with better animal models for research and finding biomarkers to better identify different kinds of pain patients.
The National Institutes of Health has already recognized these gaps in R&D, and NIH officials have been meeting with drug companies over the last year to figure out ways to work together to bridge them. But NIH Director Francis Collins has said that the public-private partnership needs funding from Congress to really get off the ground.
[Updated with details from the White House 2019 budget.] The two-year budget deal passed last week by Congress includes $6 billion over the next two years to combat opioid and mental health issues. And President Trump’s 2019 budget, released today, calls for $13 billion in new funding over two years for the US Department of Health and Human Services to tackle the opioid epidemic. The budget proposes that $500 million of this be allocated to the NIH’s public-private partnership to speed up the development of new pain and addiction drugs.
