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NIH seeks to partner with biopharma to combat opioids crisis

Top officials at the National Institutes of Health said May 31 that the agency is seeking to partner with drugmakers to accelerate the development of nonaddictive alternatives to opioids and better overdose-reversal agents, with the aim of curbing the U.S. addiction epidemic.

Francis Collins, the head of the NIH, did not identify the companies that have expressed interest in the initiative, but told reporters during a telephone briefing that the "significant science leaders from a dozen or more" biopharmaceutical firms "responded with a great deal of enthusiasm" about working with the agency on the effort to address "what we all agree is a national crisis."

"They are very much on board with the importance of carrying out this effort as a public-private partnership," Collins said.

An NIH spokeswoman later clarified for S&P Global Market Intelligence that the agency has not yet officially partnered with any firms and has only held closed-door meetings to discuss the possibility of doing so.

Over the next six weeks, the NIH plans to hold a series of three "very intense" workshops to identify "action-oriented" solutions to "offer our nation at a time of great need," Collins told reporters.

He declined to discuss how the NIH plans to pay for the initiative, given President Donald Trump has called for a nearly $6 billion cut to the agency's budget.

But Collins said the initiative was being "put very high on the list of things we just have to do."

Collins also declined to say how much the industry was expected to contribute and how the agency might be able to retrieve some of its costs through licensing agreements with drugmakers.

He pointed to another ongoing public-private collaboration as a potential model — the Accelerating Medicines Partnership, a $230 million five-year venture with 10 biopharmaceutical companies and several nonprofits aimed at speeding up treatments for Alzheimer's disease, type 2 diabetes and certain autoimmune disorders.

By partnering, the NIH and industry are hoping to reduce the costs and increase the chances that products for those diseases will succeed, according to the agency.

All hands on deck

In a May 31 New England Journal of Medicine article and a blog posted on the agency's website, Collins and Nora Volkow, the director of the NIH's National Institute on Drug Abuse, laid out their goals for the initiative, which they said must be an "all-scientific-hands-on-deck" effort.

They noted that 90 Americans die from opioid overdoses every day in the U.S. About 2 million Americans had a prescription opioid-use disorder in 2015 — something that cost the U.S. $78.5 billion in healthcare, law enforcement and lost productivity.

"But while the scope of the crisis is staggering, it is not hopeless," Collins and Volkow wrote.

Science has been one of the strongest allies in resolving public health crises, and ending the opioid epidemic "will not be any different," they said.

Improved products

The NIH leaders emphasized the need to develop improved formulations of naloxone, an agent intended to rapidly reverse opioid overdose, and additional overdose-reversal interventions.

Volkow noted her agency collaborated with Lightlake Therapeutics Inc. to create a nasal spray formulation of naloxone, which gained FDA approval in November 2015 and is sold by the firm's partner Adapt Pharma Ltd. under the brand name Narcan.

While drugs like methadone, buprenorphine and naltrexone have effectively reduced illicit opioid use, not all people respond to those agents, Collins and Volkow said.

But the growing knowledge of the neurobiology of opioid addiction has helped researchers to identify novel molecular targets and new ways of modifying brain circuits that may produce more effective and safer treatments for opioid use disorders, they said.

Vaccines that recruit the body's immune system to prevent opioids from entering the brain are among the novel approaches in development that have shown "great promise" in animal studies, the NIH officials noted.

But simply reducing the use and supply of addictive prescription opioids "does not address the very real problem of untreated pain in this country, and we cannot solve the opioid addiction and overdose crisis without better addressing pain at the same time," they said.

The government must work with the industry to develop safe, effective, nonaddictive interventions to manage chronic pain, they said.