The U.S. Food and Drug Administration
approved Cassipa (buprenorphine and naloxone) sublingual film (applied under
the tongue) for the maintenance treatment of opioid dependence.
This action provides a new
dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone
sublingual film, which is also approved in both brand name and generic versions
and in various strengths.
“There’s an urgent need to
ensure access to, and wider use and understanding of, medication-assisted
treatment for opioid use disorder. The introduction of new treatment options
has the potential to broaden access for patients. For example, the FDA recently
described a streamlined approach to drug development for certain
medication-assisted treatments that are based on buprenorphine. This
streamlined approach can reduce drug development costs, so products may be
offered at a lower price to patients and we can broaden access to treatment,”
said FDA Commissioner Scott Gottlieb, M.D. “The FDA is committed to helping
those with opioid use disorder transition to lives of sobriety. We’ve taken a
number of steps to advance the development of new FDA-approved treatments for
opioid dependence and encourage health care professionals to ensure patients
are offered an adequate chance to benefit from these therapies. We’re also
working to address the unfortunate stigma that’s sometimes associated with the
use of opioid replacement therapy as one approach to the successful treatment
of addiction. Despite what some may think, individuals who successfully
transition onto medication-assisted treatment are not swapping one addiction
for another. Opioid replacement therapy can be an important part of effective
treatment. Opioid use disorder should be viewed similarly to any other chronic
condition that is treated with medication.”
Medication-assisted
treatment (MAT) is a comprehensive approach that combines FDA-approved
medications (currently methadone, buprenorphine, or naltrexone) with counseling
and other behavioral therapies to treat patients with opioid use disorder
(OUD). Regular adherence to MAT with buprenorphine reduces opioid withdrawal
symptoms and the desire to use opioids, without causing the cycle of highs and
lows associated with opioid misuse or abuse. At proper doses, buprenorphine
also decreases the pleasurable effects of other opioids, making continued
opioid abuse less attractive. According to the Substance Abuse and Mental
Health Services Administration, patients receiving MAT for treatment of their
OUD cut their risk of death from all causes in half.
The FDA granted approval of
Cassipa to Teva Pharmaceuticals USA Inc.
Reference: FDA News
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