What Is Buvidal?

Buvidal is a relatively new medication for opioid addicts. This medication is administered, either weekly or monthly, by a physician or other authorized medical professional through subcutaneous injection. The active ingredient in Buvidal is buprenorphine, a partial mu receptor opioid agonist. The brand-name for Buvidal in the United States is Brixadi.

Buvidal is an extended-release medication for the treatment of opioid use disorder (OUD) which has proven to be highly successful in helping people to recover and live healthier lives. It is available in various dosages so that treatment can be tailored to meet the individual patient’s unique needs.

Buvidal was approved for use throughout the European Union (EU) on November 20, 2018.  Just eight days later it was approved for use in Australia. Just one month after its approval for use in the EU, on December 20, 2018, Buvidal was approved for use in Switzerland.

On that same day, December 20, 2018, the FDA granted tentative approval (TA) for use of Buvidal in the U.S. under the brand name Brixadi. TA means that a drug has passed the FDA standard for safety and efficacy and will likely be approved and made available for marketing once patents/exclusive rights expire for other drugs.

Benefits of Buvidal

In a study administered in the EU before Buvidal gained approval there, Buvidal proved more effective in helping patients test negative for opioids than an oral medication containing both buprenorphine and naloxone. While the results of one study may not be enough to state that Buvidal is more effective than other medications, it certainly shows that it’s a powerful new treatment in our battle to help people with OUD to return to relative health and safety.

A choice between weekly or monthly doses gives patients more power over their lives. However, the Buvidal (or Brixadi) injection is administered by a physician or other licensed medical provider. Physicians and other medical providers are monitored, to prevent doctor-shopping (patients don’t have access to multiple providers/doses of Buvidal at once). Patients don’t have the option of taking this medication home and injecting themselves; they must receive the injection from their licensed provider.

How Buvidal Works

Buvidal works like buprenorphine. It binds to the opioid receptors and prevents the patient from suffering withdrawal symptoms. However, because it is a partial mu receptor agonist, it doesn’t have the euphoric and sedative effects of a full mu receptor agonist such as heroin, oxycodone, or morphine.

Patients who begin treatment with Buvidal (Brixadi) must first be free of their last use of an opioid drug such as heroin, oxycodone, or fentanyl for at least 6 hours, and in the first stages of withdrawal.

Patients who transition from methadone to Buvidal must gradually reduce methadone dosage to 30 mg per day. There must be an interval of at least 24 hours after the patient’s last use of methadone before beginning Buvidal.

Patients who have never taken buprenorphine must take a small dose of buprenorphine and be monitored for about an hour before taking Buvidal.

Possible Side Effects of Buvidal (Brixadi)

While most patients report a positive result from this medication, a small percentage of patients report one or more negative side effects, including

  • Headaches
  • Insomnia or drowsiness
  • Sweating
  • Pain
  • Rash or swelling (injection-site)

Buvidal has not been approved for patients who are age 16 and under. Buvidal is not approved for use in pregnant women.

Do not use Buvidal if you suffer from any of the following:

  • kidney disease
  • liver disease
  • alcohol use disorder
  • difficulty breathing

Before starting treatment with Buvidal you must undergo a physical exam and also tell your prescribing doctor about any/all other medical conditions you suffer from and all medications you take.

Is Buvidal Available in the US?

Swedish pharmaceutical company Camurus announced on June 1, 2020 that they submitted their request for final FDA approval of Brixadi, the brand-name for Buvidal in the U.S. Though approval was expected by December 1, 2020, the FDA found deficiencies in the manufacturing facility, and these have been addressed. The new tentative date for Brixadi (Buvidal) approval in the U.S. is December 15, 2021. Camurus’s partner in the U.S. is Braeburn Pharmaceuticals.

Hopefully, as Brixadi (Buvidal) lumbers forward towards FDA approval, we can look forward to adding another highly-effective treatment option to help combat the opioid crisis here in the U.S. We are currently leading the world in the opioid-addiction crisis and related deaths. We need to turn things around so that we are leaders in helping people with OUD to obtain lifesaving treatment.