Dive Brief:
- A new industry analysis on the state of innovation in pain and addiction from the U.S. trade body BIO finds 215 clinical stage programs ongoing in pain, with 87% focusing on non-opioid receptors.
- The move towards abuse deterrence is ongoing, with 142 trials initiated, and 12 abuse-deterrent pain products approved by the Food and Drug Administration.
- In addiction treatment, there are only 15 active clinical-stage programs ongoing with novel compounds intended for addiction treatment, with two-thirds in substance abuse and the rest split between alcohol and smoking cessation.
Dive Insight:
Deaths from opioid overdoses continues to climb across the U.S. During 2016, drug overdoses hit an all-time high, with almost two thirds linked with opioids. Overdose deaths connected with synthetic opioids (other than methadone) doubled between 2015 and 2016.
Experts see no sign of the crisis abating.
The Food and Drug Administration is urging a range of changes, including modifying dosing and prescription length, improving access to addiction treatment, changing packaging and supporting the development of less addictive pain therapeutics. This week's analysis from BIO focuses on both the strengths and weaknesses of the current drug development perspective.
While a pipeline of 215 drugs in the clinic may seem impressive, only a very small percentage of these are likely to reach the market at the current attrition rates, according to report author David Thomas, senior director of industry research & policy analysis for BIO. The FDA approval success rate across all diseases is 10%; the rate for approval from Phase 1 for pain therapeutics is only 2%.
Of these, some may target specific types of pain, such as migraine, and so only a fraction will fill the need for non-opioid approaches to chronic pain. For example, over the last decade, there have only been two completely new drugs approved to treat pain. The numbers of drugs in development to treat addiction are around ten-fold lower.
"Combating our nation’s opioid epidemic… 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," said BIO president and CEO Jim Greenwood.
Marketing, patient group ties questioned
Companies with opioids already on the market have taken their share of criticism for their role in the crisis. A Senate report out this week is the latest to question drugmaker marketing of the products and its influence over patient groups.
Purdue Pharma L.P., Janssen Pharmaceuticals, Inc., Mylan N.V., Depomed, Inc., and Insys Therapeutics, Inc., paid out nearly $9 million to 14 advocacy groups working on chronic pain and other opioid-related issues between 2012 and 2017, according to a report from Missouri Democratic Senator Claire McCaskill.
The report also accuses the groups of issuing guidelines and policies that both minimize the risk of opioid addiction and promote opioids for chronic pain, as well as lobbying to change laws that could curb opioid use, and arguing against accountability for those responsible for over-prescription and misbranding.
"By aligning medical culture with industry goals in this way, many of the groups described in this report may have played a significant role in creating the necessary conditions for the U.S. opioids epidemic," the report states in conclusion.
Purdue this week said it would stop marketing its opioid Oxycontin to doctors, after years of criticism over its practices.
The five manufacturers also paid an additional $1.6 million between 2013 and today to physicians linked with these groups, according to the report.
The report states: "Initiatives from the groups in this report often echoed and amplified messages favorable to increased opioid use – and ultimately, the financial interests of opioid manufacturers."