Teva Pharmaceuticals received the final approval from the US Food and Drug Administration (FDA) for a generic naloxone nasal spray, developed to stop or reverse the effects of an opioid overdose.
The FDA tentatively approved Teva’s generic drug on June 8, 2018. Previously, a brand-name naloxone nasal spray was approved, as well as an auto-injector for use by those without medical training.
The FDA gave the green light for manufacturers to pursue approvals for over-the-counter naloxone products, as it aims to increase access to emergency treatment.
Deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, Douglas Throckmorton stated that the FDA is also considering compulsory co-prescription of the spray “with all or some opioid prescriptions, to reduce the risk of overdose death.”
The opioid crisis resulted in the death of almost 400,000 people in the US from 1999 to 2017, according to the Centers for Disease Control and Prevention. On average, more than 130 Americans die every day from overdoses involving opioid prescription medications such as fentanyl, oxycodone, hydrocodone and morphine.
As part of its Five-Point Opioid Strategy, in order to fight the opioid crisis, the US Department of Health and Human Services runs a State Opioid Response grant program, with a total amount of provided of $1.4bn (€1.25bn) for 2019.
Recently, the FDA issued two warning letters to operators of websites that market unapproved opioid medications, such as tramadol, increasing the number of warning letters issued regarding such behaviour to 25 since September 2017.