FDA Approves Braeburn’s Extended-Release Injection Brixadi for Opioid Use Disorder Treatment
The US Food and Drug Administration (FDA) has approved Braeburn’s Brixadi, a subcutaneous extended-release injection available in weekly or monthly treatments for opioid use disorder (OUD) patients. The newly approved treatment option is available for patients who have started treatment with a single dose of a transmucosal buprenorphine product or those who are already being treated with buprenorphine. The weekly doses of Brixadi will range from 8 mg to 32 mg, while the monthly doses will be 64 mg, 96 mg, and 128 mg. The lower doses of the extended-release injection offer a new and accessible route to treatment for patients in recovery who struggle with treatment adherence, according to the FDA.
Data from a 24-week Phase III trial (NCT02651584) was submitted by Braeburn to support the FDA approval. The study involved 428 adults with moderate to severe OUD, where Brixadi performed similarly to daily sublingual buprenorphine with naloxone, meeting its non-inferiority endpoint.
The FDA approval adds a further treatment avenue to tackle the opioid crisis in the US. The pharma industry has been relatively slow in developing new treatments due to an array of legal challenges posed to pharma companies and pharmacies implicated in the crisis. Most recently, Walgreens paid $230m to the city of San Francisco for contributing to the epidemic.
The year 2023 has seen some landmark regulatory developments to contain the crisis. In March, the FDA approved OTC Narcan to help improve access to treatment for instances of overdose. Then, in April, the FDA issued a notice to opioid analgesics manufacturers outlining the requirement of mail-back envelopes to prevent unused products from reaching the hands of friends or relatives. In late May, the FDA approved Indivior’s Opvee nasal spray to reverse opioid overdose.
The FDA has issued a joint letter with Substance Abuse and Mental Health Services Administration (SAMHSA) to highlight the importance of a comprehensive treatment plan with associated counseling. In the letter, the FDA was keen to highlight that participation in such health resources should not be a prerequisite or requirement for the prescription of buprenorphine, to ensure that as many treatment options as possible are available for those who need it.
“Buprenorphine is an important treatment option for opioid use disorder. Today’s approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery,” said FDA Commissioner Dr. Robert Califf.
Dr. Michelle Lofwall, primary investigator in the Phase III study and a professor at University of Kentucky, Lexington, said, “Some patients need help with taking their medication as prescribed, some prefer not taking a daily medication or visiting a pharmacy to pick up their medication. Having a weekly and monthly option that provides buprenorphine over one week or one month could benefit patients, their loved ones, and treatment providers.”
- Opioid use disorder treatment
- FDA-approved long-term treatment for opioid addiction
- Medication-assisted treatment for opioid dependency
- Buprenorphine treatment for opioid addiction
- FDA-approved addiction medication
News Source : Robert Barrie
Source Link :FDA greenlights new long-term treatment option for opioid use disorder/