BIO Releases Report on State of Innovation for Pain and Addiction Therapeutics

Washington, DC (February 12, 2018) – Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases: Pain and Addiction Therapeutics. While many promising treatment approaches are in development, lower investment and pipeline breadth in pain and addiction relative to other disease areas with high societal health burdens demonstrates the need for incentivizing more research and clinical development in these areas.

”America’s biopharmaceutical companies are committed to combating our nation’s opioid epidemic,” said BIO President and CEO Jim Greenwood. “This will depend upon biomedical innovation and the development of novel and safer, next generation therapies to treat both pain and addiction, which together cost our country more than $1 trillion annually. While there are promising technologies under development, more must be done to stimulate research and development for these areas of high unmet need.”

The report analyzed the last decade of clinical trial activity, FDA approvals, and venture investment as well as the breadth and depth of the current pipeline for novel therapies in pain and addiction.

Key Takeaways

• There have been only two novel chemical entities FDA approved to treat pain over the past decade.
• The industry-wide pain pipeline consists of 215 clinical-stage drug programs, with 125 of these testing novel chemical entities in the clinic, 87% of which are for non-opioid receptors. These are relatively low numbers when compared to the current pipeline for oncology (2,617 total programs and 1,700 novel drug clinical-stage programs).]Over the past decade, the biopharmaceutical industry has been working to develop abuse deterrent formulations, with 142 clinical trials initiated and 12 FDA approvals for abuse deterrent pain products.
• Clinical success in pain drug development has been extremely difficult for novel drugs, with only a 2% probability of FDA approval from phase I, compared to an overall 10% success rate across all diseases.
• Private company investment, as measured by venture capital into US companies with lead stage programs in pain, is 3.6% of total drug development venture funding. For venture funding of novel R&D, pain has received 17 times less venture capital than oncology over the last decade.
• There are only 15 active clinical-stage programs with novel compounds intended for addiction treatment: 10 for substance abuse, two for alcohol, and three for smoking cessation.
• Venture investment for addiction drug R&D is nearly non-existent.

“On the surface, 125 clinical-stage-programs utilizing 20 unique mechanistic strategies sounds impressive. However, with a success rate over the last decade of a mere 2 percent, only a few of these may actually reach FDA approval. 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 report author David Thomas, Senior Director, Industry Research & Policy Analysis for BIO. “The addiction pipeline has 10-fold fewer clinical-stage programs than pain, suggesting a need for incentivizing innovation in this space.”

The report – The State of Innovation in Highly Prevalent Chronic Diseases: Pain and Addiction – is available for download here: www.bio.org/iareports.