New naloxone provides more opioid overdose options

September 25, 2018

Pharmacy and healthcare experts cautiously praised the planned development of a fast-acting, better version of naloxone (Narcan), which is used to reverse the effects of opioid overdoses.

Pharmacy and healthcare experts cautiously praised the planned development of a fast-acting, better version of naloxone (Narcan), which is used to reverse the effects of opioid overdoses.

The US Department of Health and Human Services (HHS) said it will work with Opiant Pharmaceuticals in Santa Monica, Calif., to develop a fast-acting, long-lasting intranasal form of naloxone called nalmefene.

“The life-saving drug naloxone, while effective, often must be given multiple times to completely reverse the effects of an opioid in someone  exposed to high doses. Repeat doses of the treatment may not always be feasible, especially in a large-scale terrorist attack,” said Rick Bright, PhD, director of the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, in a statement from HSS.

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“Improved opioid exposure treatments are critical to adequately address this growing threat to public health and health security,” Bright added.

Because of the shorter half-life of naloxone compared to fentanyl derivatives, repeat dosing of naloxone often is needed to fully reverse the effects of the drug, HHS said. “Nalmefene acts in the same way as naloxone and studies suggest that it may work for much longer,” HHS said in the statement.

“Choice in the marketplace is a really good thing. This dosage delivery device provides another option for patients,” John Beckner, senior director of strategic initiatives at National Community Pharmacists Association (NCPA), told FormularyWatch.

If nalmefene is available by prescription only, NCPA would ask state boards of pharmacy to allow pharmacists to prescribe it. “We would like it treated the same way as naloxone is, so there is easy access to it,” Beckner said.

Related: FDA issues guidance on opioid use disorder meds

“Having a more potent and longer-duration medication may help prevent those deaths that occur due to under-management or those who do not have access to medical providers,” Steven Moskowitz, MD, senior medical director of Paradigm Outcomes, told FormularyWatch.

However, a potential negative effect of a long-acting option to naloxone may be that accidental users may forgo medical attention if they think it is not necessary, Moskowitz said. “An overdose suggests out-of-control drug use. People who survive an overdose need to access medical attention and treatment, since next time they may not be so lucky.”

Opiant received a one-year, approximately $611,000 contract with BARDA, which can be extended up to a total of $4.6 million over 3 years for work necessary to apply for FDA approval.

While injection nalmefene is approved by FDA for opioid overdoses, the drug was removed from the US market in 2008 due to low sales and is no longer available, HHS said. “Returning nalmefene to market in an easy-to-administer intranasal formulation may be an important addition to the nation’s preparedness for current and emerging opioid threats.”

Read more: FDA warns about opioid-containing supplement