FDA Advisory Committee to Discuss Proposed OTC Naloxone

The Food and Drug Administration (FDA) has issued a Federal Register notice announcing a joint public advisory committee meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The Committee will meet on February 15th to discuss a supplemental new drug application for an over the counter version of naloxone nasal spray which, if approved, would be the first over the counter 4-mg naloxone nasal spray available in the United States. This notice follows the agency’s November 2022 announcement which noted that certain naloxone drug products of up to 4 milligrams nasal spray and up to 2 mg autoinjector for intramuscular or subcutaneous use may be “approvable as safe and effective for nonprescription use” and encouraged naloxone manufactures to contact the agency to initiate discussions about switching from prescription to over the counter. FDA has established a public docket (FDA–2022–N–3245) and is requesting public comments for this meeting by February 14th.

Articles & Resources

FDA – February 15, 2023: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement

CDER Releases Findings of Survey to Detect Illicit Fentanyl in Opioid Pharmaceutical Supply Chain

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) released the results of their multi-year opioid product quality survey, which was developed by CDER’s Office of Compliance to test active pharmaceutical ingredients and detect substitutions of illegal and unsafe substances – such as fentanyl – within the supply chain of FDA-regulated opioids. FDA tested FDA-regulated opioids, ingredients used to make opioids, opioid overdose reversal products, and opioid addiction treatment products and found no evidence of illegal substitution in any of the tested ingredients and products. According to FDA, the agency’s surveillance efforts are part of their Overdose Prevention Framework and the agency plans to continue ongoing testing of additional products to secure the supply chain of FDA-regulated opioids and address the “rapid growth of the sale of illicit, chemically synthesized fentanyl, fentanyl analogs.”

Articles & Resources

FDA – Examining Ingredient Substitution in the Opioid Pharmaceutical Supply Chain: Findings from CDER’s Product Survey

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the topic. Links to relevant articles are provided below.

Axios – Surging opioid overdoses prompt more Americans to carry Narcan spray

Boston Globe – Let pharmacists prescribe addiction medicine

Boston Globe – Making opioid addiction treatment available at pharmacies may dramatically increase positive outcomes, study shows

Clinical Pain Advisor – Buprenorphine May Be Preferred Over Methadone for Use During Pregnancy

CNN – Naloxone is reaching more people than ever

JAMA Network Open – Effect of Prescriber Notifications of Patient’s Fatal Overdose on Opioid Prescribing at 4 to 12 Months: A Randomized Clinical Trial

Journal of Clinical Oncology – Racial and Ethnic Disparities in Opioid Access and Urine Drug Screening Among Older Patients With Poor-Prognosis Cancer Near the End of Life

NHPR – A new law could make it easier to access an effective opioid addiction treatment in NH

Office of Governor Gavin Newsom – California Invests $52 Million in Opioid Prevention and Treatment

Physician’s Weekly – Evaluating the Link Between Opioid Overdose, Buprenorphine Treatment Gaps and Health Care Spending

Politico – Emergency’s end could curtail virtual prescribing

STAT – For addiction treatment, longer is better. But insurance companies usually cut it short

The Washington Post – How to safely dispose of old medications, according to experts

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

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