Commercialization: Marketing & Distribution
U.S. FDA panel to review Emergent's OTC opioid overdose drug
Reuters - 11 Jan, 2023
The U.S. health regulator said on Tuesday its advisory panel will meet on Feb. 15 to review Emergent Biosolutions Inc's (EBS.N) over-the-counter (OTC) nasal spray to treat suspected opioid overdoses.
Emergent is seeking the Food and Drug Administration's (FDA)approval for the prescription-free sale of Narcan, its nasal spray form of the drug naloxone. Narcan is already cleared for the treatment of opioid overdose in the country.
Last month, the health agency accorded Narcan's marketing application a priority review status, and is set to make its decision by March 29. The panel will assess the adequacy of data that supports the nonprescription use of the drug.
The country's worsening opioid crisis has prompted the Biden administration to develop newer strategies, including the use of naloxone, a medication that can reverse opioid overdoses.
Late last year, the agency had said naloxone might be safe and effective for over-the-counter use in some forms, potentially paving the way for its use federally and encouraging more manufacturers to seek approval for prescription-free use.
Government estimates peg drug-related overdose deaths in the United States at more than 100,000 during 2021, a near 15% increase from the year earlier.
The U.S. health regulator said on Tuesday its advisory panel will meet on Feb. 15 to review Emergent Biosolutions Inc's (EBS.N) over-the-counter (OTC) nasal spray to treat suspected opioid overdoses.
Emergent is seeking the Food and Drug Administration's (FDA)approval for the prescription-free sale of Narcan, its nasal spray form of the drug naloxone. Narcan is already cleared for the treatment of opioid overdose in the country.
Last month, the health agency accorded Narcan's marketing application a priority review status, and is set to make its decision by March 29. The panel will assess the adequacy of data that supports the nonprescription use of the drug.
The country's worsening opioid crisis has prompted the Biden administration to develop newer strategies, including the use of naloxone, a medication that can reverse opioid overdoses.
Late last year, the agency had said naloxone might be safe and effective for over-the-counter use in some forms, potentially paving the way for its use federally and encouraging more manufacturers to seek approval for prescription-free use.
Government estimates peg drug-related overdose deaths in the United States at more than 100,000 during 2021, a near 15% increase from the year earlier.