FDA Roundup: Rosacea Treatment, Proposal to Remove Oral Phenylephrine from OTC Products
Check out these important FDA updates from the week of November 4.
FDA Approves Journey Medical’s Emrosi for Rosacea
FDA Roundup: Rosacea Treatment, Proposal to Remove Oral Phenylephrine from OTC Products / Tada Images - stock.adobe.com
The FDA approved minocycline hydrochloride extended-release capsules (40 mg; Emrosi), formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults. The approval of minocycline hydrochloride extended-release capsules is supported by positive data from Journey Medical’s two phase 3 clinical trials for the treatment of rosacea, MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455). Participants completed the 16-week treatment with no significant adverse effects and the most common adverse event was dyspepsia.
Minocycline hydrochloride extended-release capsules were more effective than both the current standard treatment, Oracea 40 mg capsules, and a placebo in both studies. This was demonstrated by a higher success rate as assessed by the Investigator’s Global Assessment and a greater reduction in the total number of inflammatory lesions.
Journey Medical is currently finalizing the production of minocycline hydrochloride extended-release capsules for the US market. The company expects initial supplies to be available late in the first quarter or early in the second quarter of 2024, and the company plans to commercialize the therapy in the US through its dermatology-focused commercial organization.
FDA Proposes to Remove Oral Phenylephrine as OTC Monograph Nasal Decongestant
The FDA has proposed to remove oral phenylephrine as an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion. The decision was made after an extensive review found the available data determined that oral phenylephrine is not effective for this use.
Oral phenylephrine is a widely used nasal decongestant that is the active ingredient in many popular OTC products. It is typically used as the sole active ingredient or in combination with another active ingredient, such as acetaminophen or dextromethorphan. The FDA said that it is currently seeking public comments on this proposed order. After public comments have been evaluated, the agency will issue a final order.
“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,” Theresa Michele, MD, director of the Office of Nonprescription Drug Products in CDER, said in a release.1 “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”
FDA Expands OA REMS, Mandates Mail-Back Envelopes for Opioid Analgesics
Starting March 31, 2025, companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) program must provide pre-paid drug mail-back envelopes to outpatient pharmacies and other dispensers of opioid analgesics upon request, per an approved update to the framework by the FDA.
The update was approved on October 31, 2024, and aims to provide patients and caregivers with a convenient way to safely dispose of any unused or expired opioid analgesics. In partnership with the US Postal Service, mail-back envelopes will be available through outpatient pharmacies or other dispensers of opioid analgesics that order from the OA REMS program.
The approval of the program underscores a significant shift towards drug disposal strategies aimed at curbing overdose fatalities and the larger opioid epidemic. The Drug Enforcement Administration’s National Prescription Take Back Day, held on the last Saturday of April and October, offers nationwide collection sites for safe medication disposal.Additionally, many large pharmacy chains, such as CVS, Walgreens, and Walmart, have installed convenient medication disposal kiosks in their stores across the country.
