FDA Approves New Sublingual Films to Treat Opioid Dependence

FDA Approves New Sublingual Films to Treat Opioid Dependence

The FDA has approved a new 16 mg/4 mg buprenorphine-naloxone sublingual film to treat opioid dependence. Called Cassipa, it is made by Teva Pharmaceuticals USA Inc.

In June, the FDA also approved the first generic versions of buprenorphine-naloxone sublingual film for opioid dependence. Mylan Technologies Inc., and India's Dr. Reddy's Laboratories SA, received approval to market multiple strengths of this product.

“There's an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder,” said FDA Commissioner Scott Gottlieb, M.D. “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.”
"Teva's high-dosage product “should be used as part of a complete treatment plan that includes counseling and psychosocial support and should only be used after patient induction and stabilization up to a dose of 16 milligrams of buprenorphine using another marketed product,” the FDA said in its announcement of the approval."

Fast track approvals

"Teva's Cassipa was approved through the FDA's “abbreviated approval” 505(b)(2) pathway. The FDA announcement explains that new drug applications submitted through the 505(b)(2) pathway “may rely on the FDA's finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified.”

Teva's application relied at least partially on earlier approvals for other buprenorphine-naloxone sublingual films (e.g., Suboxone from Indivior) that demonstrated safety and effectiveness at various dosages.

Cassipa's dosage of 16 mg buprenorphine to 4 mg naloxone is the highest dosage now available. It follows the usual 4 to 1 ratio used in Suboxone and Zubsolv, two well-known brands of sublingual films widely used for opioid dependence.

Suboxone and Zubsolv dosages are:

  • Suboxone: 2 mg/0.5 mg; 4 mg/1 mg; 8 mg/2 mg; 12 mg/3 mg.
  • Zubsolv: 0.7 mg/0.18 mg; 2.9 mg/0.71 mg; 5.7 mg/1.4 mg; 8.6 mg/2.1 mg; 11.4 mg/2.9 mg.

A third brand, Bunavail, is a “buccal” (in the cheek) film. It is provided in ratios of 6 or 7 to 1.

  • Bunavail: 2.1 mg/ 0.3 mg; 4.2 mg/ 0.7 mg; 6.3 mg/1 mg.

Dr. Reddy's immediately announced its generic sublingual film will be available in 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg - identical to the industry leader, Suboxone.

Mylan has not yet announced what dosages its product will include.

“The FDA is committed to helping those with opioid use disorder transition to lives of sobriety,” Gottlieb said. “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.”
"He added that the FDA wants to end the stigma sometimes associated with opioid replacement therapy. “Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication.”

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