The FDA has made several key announcements, including the approval of Journey Medical's Emrosi for rosacea and a proposal to remove oral phenylephrine from OTC nasal decongestants. These decisions reflect the agency's ongoing efforts to ensure the safety and efficacy of medications available to the public.
Emrosi Approved for Rosacea Treatment
The FDA has approved minocycline hydrochloride extended-release capsules (40 mg), marketed as Emrosi by Journey Medical, for the treatment of inflammatory lesions of rosacea in adult patients. The approval is based on data from two Phase 3 clinical trials, MVOR-1 and MVOR-2, which demonstrated the drug's efficacy and safety.
In these trials, participants underwent a 16-week treatment period. The results indicated that Emrosi was more effective than both placebo and Oracea (minocycline) 40 mg capsules, a current standard treatment for rosacea. The effectiveness was measured by the Investigator’s Global Assessment and the reduction in the total number of inflammatory lesions. The most common adverse event reported was dyspepsia, with no significant adverse effects observed.
Journey Medical anticipates making Emrosi available in the US market in late Q1 or early Q2 2024, commercializing the therapy through its dermatology-focused organization.
Proposal to Remove Oral Phenylephrine from OTC Products
The FDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) monograph drug products intended for temporary relief of nasal congestion. This decision follows an extensive review of available data, which concluded that oral phenylephrine is not effective as a nasal decongestant.
Oral phenylephrine is commonly found in many OTC products, either as the sole active ingredient or in combination with other drugs like acetaminophen or dextromethorphan. The FDA is currently seeking public comments on this proposed order before issuing a final decision.
According to Theresa Michele, MD, director of the Office of Nonprescription Drug Products in CDER, "Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold. Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms."
Opioid Analgesic REMS Program Update
Starting March 31, 2025, companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) program will be required to provide pre-paid drug mail-back envelopes to outpatient pharmacies and other dispensers of opioid analgesics upon request. This update, approved on October 31, 2024, aims to provide a convenient and safe way for patients and caregivers to dispose of unused or expired opioid analgesics.
In partnership with the US Postal Service, these mail-back envelopes will be available through outpatient pharmacies or other dispensers of opioid analgesics that order from the OA REMS program. This initiative is part of a broader effort to combat overdose fatalities and the opioid epidemic, complementing existing programs such as the Drug Enforcement Administration’s National Prescription Take Back Day and medication disposal kiosks in pharmacies like CVS, Walgreens, and Walmart.
