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General Information

Zubsolv is a sublingual tablet formulation of buprenorphine, an opioid analgesic, and naloxone, an opioid antagonist. It was designed to counteract the high effect that may arise following the intravenous injection of a disolved tablet. Combining buprenorphine and naloxone in a single tablet reduces the risk of intravenous abuse.

Zubsolv is specifically indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

Zubsolv is supplied as a tablet for sublingual administration. The recommended target dosage of Zubsolv sublingual tablet is 11.4 mg/2.8 mg buprenorphine/naloxone/day (two 5.7/1.4 mg tablets) as a single daily dose. The dosage of Zubsolv should be progressively adjusted in increments/decrements of 1.4 mg/0.36 mg or 2.8 mg/0.72 mg buprenorphine/naloxone to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.

Clinical Results

FDA Approval
The FDA approval of Zubsolv was based on efficacy data from a drug that has already been approved, Suboxone. Approval was also based on bioavailability and pharmacokinetic studies. Compared with other buprenorphine/naloxone treatments, Zubsolv has higher bioavailability, faster dissolve time, and smaller tablet size with a new menthol taste.

Side Effects

Adverse effects associated with the use of Zubsolv may include, but are not limited to, the following:

headache
nausea
vomiting
hyperhidrosis
constipation
signs and symptoms of withdrawal
insomnia
pain
peripheral edema

Mechanism of Action

Zubsolv ontains buprenorphine and naloxone. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is a potent antagonist at mu-opioid receptors and produces opioid withdrawal signs and symptoms, if administered parenterally, in individuals physically dependent on full opioid agonists.