The FDA said the approval of Teva’s product is the first generic naloxone nasal spray for use in a community setting by individuals without medical training.
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The U.S. Food and Drug Administration (FDA) granted approval for the first generic version of Narcan, an anti-overdose drug that has become an essential tool in the arsenal against the opioid crisis cutting a deadly swath through the United States.
Late Friday the regulatory agency announced it gave approval to Teva Pharmaceutical‘s generic naloxone hydrochloride nasal spray. The FDA said the approval of Teva’s product is the first generic naloxone nasal spray for use in a community setting by individuals without medical training. Narcan, which was developed by Opiant Pharmaceuticals and licensed to Adapt Pharma (which was acquired last year by Emergent BioSolutions for $735 million), has become the go-to option for law enforcement and first responder agencies across the United States as a tool to combat opioid overdoses. Last week the White House added an additional $350 million into an anti-opioid abuse initiative that includes the increased availability of naloxone in multiple communities across four states that have been ravaged by opioid-related deaths. The goal of this investment is to reduce opioid-overdose deaths by as much as 40 percent in those. The approval of Teva’s generic of Narcan came one day after the White House announced that funding.
Despite the increased awareness about the issue of opioid-abuse, overdoses from the product (both of legal and illegal opioids) take the lives of about 130 Americans each day. Since 1999, more than 400,000 Americans have died from opioid overdoses, the FDA said, citing statistics from the Centers for Disease Control and Prevention.
Douglas Throckmorton, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said that due to the severity of the opioid crisis, there are numerous efforts underway to make naloxone more readily available and more accessible. Moving forward, Throckmorton said the FDA will prioritize its review of generic drug applications for naloxone.
“The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death,” Throckmorton said in a statement. “All together, these efforts have the potential to put a vital tool for combatting opioid overdose in the hands of those who need it most – friends and families of opioid users, as well as first responders and community-based organizations. We’re taking many steps to improve availability of naloxone products, and we’re committed to working with other federal, state and local officials as well as health care providers, patients and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction.”
In February, the FDA drafted new plans that will allow it to address past mistakes regarding the opioid crisis and “get ahead” of the opioid crisis. In addition to the approval of Teva’s generic, The FDA said it is planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.
