Indivior (LON:INDV) shares jumped today after the FDA approved its once-monthly buprenorphine injection for the treatment of opioid addiction in adult patients who have started therapy with a transmucosal buprenorphine product.
The company’s once-monthly injection is the first medication-assisted treatment option of its kind, the regulatory agency touted. Before Indivior’s Sublocade was approved, all other available buprenorphine-based treatment options were administered as a tablet, film or via an implant.
“Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety. Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each individual patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan,” FDA Commissioner Dr. Scott Gottlieb said in prepared remarks.
“As part of our ongoing work in supporting the treatment of those suffering from addiction to opioids, the FDA plans to issue guidance to expedite the development of new addiction treatment options. We’ll continue to pursue efforts to promote more widespread use of existing, safe and effective FDA-approved therapies to treat addiction.”
Throughout his time as head of the FDA, Gottlieb has been an advocate for medication-assisted treatment. He has repeatedly argued that part of the FDA’s job is to speed up approval of effective drugs to help expand treatment options for people suffering from opioid use disorder.
Medication-assisted treatment has long been associated with a stigma, with critics arguing that people are simply replacing one drug with another.
“The stigma reflects a view some have that a patient is still suffering from addiction even when they’re in full recovery, just because they require medication to treat their illness,” Gottlieb said in a testimony before Congress in October.
Sublocade is injected by a healthcare professional subcutaneously as a solution. Under the skin, it forms a solid depot. After the deposit is formed, buprenorphine slowly releases over the course of one month.
The drug-device product was evaluated in two clinical trials involving 848 adults with moderate-to-severe opioid addiction. All of the trial participants initially began treatment with a buprenorphine-naloxone film that absorbed under the tongue. Once the buprenorphine dose was considered to be stable, patients were given Sublocade.
The researchers found that patients treated with Sublocade had more weeks without positive urine tests or self-reports of opioid use compared to the placebo group.
The FDA said it is requiring post-market studies to identify which patients would benefit from a higher dosing regimen and to determine if Sublocade could be safely given without patients first needing to take sublingual buprenorphine.
INDV shares were trading at $536.95 apiece today, up 7%.
(1 British pound = $1.35 USD)
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.