Opioid Use Disorder (OUD)
This week, the FDA approved Brixadi (buprenorphine) extended-release injection for subcutaneous use to treat moderate to severe OUD. Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine.
Prescriptions for buprenorphine now only require a standard DEA registration number. The x-waiver is no longer required for any prescriber to treat patients with buprenorphine for opioid use disorder.
Opioid Overdose
This week, the FDA approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older.
In March, the FDA approved Narcan, 4 mg naloxone hydrochloride nasal spray for over-the-counter use – the first naloxone product approved for use without a prescription.