WASHINGTON — The FDA has approved a new sublingual film formulation of the opioid dependence treatment combination buprenorphrine/naloxone (Suboxone).
The new formulation will be released in the same 2 mg buprenorphrine/0.5 mg naloxone and 8 mg buprenorphrine/2 mg naloxone doses as the drug’s sublingual tablet form.
„During clinical tests, Suboxone sublingual film was shown to be faster dissolving than Suboxone sublingual tablets,“ Shaun Thaxter, president of manufacturer Reckitt Benckiser Pharmaceuticals, said in a prepared statement.
Drug approval included a risk evaluation and mitigation strategy program, which requires the company to monitor patients to determine whether potential treatment benefits outweigh potential risks, especially with accidental overdose, misuse, and abuse of the film, the brief said.
The drug can be abused in ways similar to other opioids. Healthcare professionals should monitor patients for proper use, the company said in the statement.
Buprenorphrine reduces patient opioid cravings and withdrawal symptoms, and also blocks the effects of other opioids. Naloxone triggers withdrawal symptoms in patients who crush and inject the drug, but has limited bioavailability when taken sublingually, and should cause no adverse events.
Chronic use of the drug may result in physical dependence and a sudden or rapid decrease in dose may result in withdrawal symptoms, though the symptoms are milder and more delayed than those occurring with full opioid agonists, the brief said.
Patients taking the film, particularly if injected or through other improper means and with central nervous system depressants, may experience life-threatening respiratory depression or death. Healthcare professionals should consider a reduced dose of the central nervous system depressant, the combination, or both when prescribing buprenophrine/naloxone, the statement said.
Pediatric patients taking the drug may have severe, potentially fatal respiratory depression.
Those taking the film should have liver function monitored before and during drug treatment.
Patients who take the drug prior to use or abuse of other full agonists, such as heroin or oxycodone, may experience withdrawal symptoms due to interactions with the drug’s naloxone.
Healthcare professionals should only prescribe pregnant or nursing patients the drug combination if potential gain outweighs potential risk, due to possible neonatal withdrawal symptoms associated with the drug, according to the manufacturer.
The drug is contraindicated in patients hypersensitive to buprenophrine or naloxone.
Adverse events associated with the film include numb mouth, sore tongue, mouth redness, headache, nausea, vomiting, sweating, constipation, insomnia, pain, swelling of limbs, attention disturbance, palpitations, blurred vision, cytolytic hepatitis, jaundice, and anaphylactic shock.