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FDA Approves First Generic Versions of Suboxone Sublingual Film

However, patent dispute will delay one launch

The FDA has approved the first generic versions of Suboxone (buprenorphine and naloxone, Indivior PLC) sublingual film for the treatment of opioid dependence.

“The FDA is taking new steps to advance the development of improved treatments for opioid use disorder and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access,” said FDA Commissioner Scott Gottlieb, MD, in a press release. “The FDA is also taking new steps to address the unfortunate stigma that’s sometimes associated with the use of opioid replacement therapy as a means to successfully treat addiction. Patients addicted to opioids who are eventually treated for that addiction, and successfully transition onto medicines like buprenorphine, aren’t swapping one addiction for another, as is sometimes unfortunately said. They’re able to regain control of their lives and end all of the destructive outcomes that come with being addicted to opioids. When coupled with other social, medical, and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence.

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. 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 opioid use disorder cut their risk of death from all causes in half.

One of the ways the FDA is encouraging access and wider use of MAT is through the approval of generic versions of these products. In an effort to promote competition to help reduce drug prices and improve access to safe and effective generic medicines for Americans, the agency is taking a number of new steps as part of its Drug Competition Action Plan. This includes important work to improve the efficiency of the generic drug approval process and address barriers to generic drug development. Generic drugs approved by the FDA have, among other things, the same quality as brand-name drugs. Generic drug manufacturing and packaging sites must meet the same quality standards as those of brand-name drugs.

Adverse events commonly observed with the buprenorphine and naloxone sublingual film are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. These products may only be prescribed by Drug Addiction Treatment Act (DATA)-certified prescribers.

Mylan Technologies, Inc., and Dr. Reddy's Laboratories SA received FDA approval to market buprenorphine and naloxone sublingual film in multiple strengths. However, Indivior has been granted a temporary restraining order to stop Dr. Reddy’s launch activities, which is a result of an ongoing patent dispute. The status of Mylan’s launch of the product is unknown at this time.

Source: FDA, June 14, 2018; and Indivior, June 15, 2018.

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