(Biotechnology Innovation Organization)
12 February 2018. A report by a biotechnology industry organization says development efforts and financing for new drugs to treat pain and addiction are falling behind the health and safety needs of society. The Biotechnology Innovation Organization or BIO released its report, “The State of Innovation in Highly Prevalent Chronic Diseases: Pain and Addiction Therapeutics,” today.
BIO’s report is motivated in part by the continuing crisis in the U.S. in opioid addiction. The problem is intertwined with relief and management of pain, for which opioid drugs are usually prescribed. Opioids work by reducing the intensity of pain signals to the brain, particularly regions of the brain controlling emotion, which reduces effects of the pain stimulus. Examples of leading opioid prescription pain medications are hydrocodone, oxycodon, morphine, and codeine. Heroin is also considered an opioid.
The scale of the opioid abuse problem is huge. A report by the National Academies released in July 2017 says as of 2015, some 2 million Americans age 12 and older are addicted prescription opioid drugs, while 600,000 are addicted to heroin. Drug overdose, mainly by opioids, is now the leading cause of death from unintentional injury in the U.S. About 90 Americans die each day from opioid overdoses, and since 2011, the number of overdose deaths tripled from illicit opioids, such as heroin and fentanyl, a synthetic opioid.
The new report, prepared by 2 analysts employed by BIO, finds pharmaceutical and biotechnology companies have 220 new drugs for pain in their pipelines, with 125 of those treatments in clinical trials. The vast majority of these new therapies (87%) target non-opioid receptors to relieve pain, indicating they use different mechanisms from opioid drugs. By comparison, pharma and biotech companies have more than 2,600 new cancer therapies in development, of which 1,700 are in clinical trials.
Over the past 10 years, says the report, the industry mounted 142 clinical trials for pain drugs formulated to deter abuse, with 12 of those compounds later approved by FDA. Yet, during this same period, FDA approved only 2 drugs that use new biochemical mechanisms for pain. One reason for this low number of FDA approvals is the low success rate for new pain drugs in clinical trials. The report says only 2 percent of new chemical mechanisms for pain make it past early-stage clinical trials to FDA approval, compared to about 10 percent for the industry overall.
The outlook for drugs to treat addiction is even less promising, according to the report. For all types of substance abuse and addiction — alcohol, tobacco, opioids, and other stimulants — only 15 treatments are in pharma and biotech company pipelines beyond preclinical stages, with 5 of those 15 new therapies for alcohol abuse or smoking cessation.
The authors point to a lack of meaningful investment in pain and addiction drugs, particularly from venture capital companies, as part of the problem. From 2007 to 2016, companies with lead drug development programs of any kind dealing with pain received $1.5 billion in venture financing, with $576 million going specifically for new mechanisms to treat pain. In comparison, companies making drugs for cancer with new treatment mechanisms received $10.3 billion over this 10-year period.
For new addiction drugs, the report says, “Venture investment into U.S. companies with lead products in addiction has been virtually nonexistent over the past 10 years.” The authors could find only $16 million over the past 10 years invested in 2 companies with lead products treating addiction, and their products were for alcohol, not drug abuse.
The report notes that new incentives for development of pain and addiction drugs may be needed. The authors cite data that show even with a large potential market, more than 90 percent of current drugs prescribed for pain have a generic option. These and other challenges create uncertainties for investors, even for financing highly innovative drugs.
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- Two Opioid Addiction Treatments Found Safe, Effective
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