Braeburn Pharmaceutical’s Probuphine Got FDA Approval as Treatment for Opioid Dependence

It is a call for celebration for Braeburn Pharmaceutical as their Probuphine Implant finally got its FDA approval. This is the first drug implant to be used for the treatment of Opioid dependence.

Patients have now an option to use Probuphine in the six month treatment for opioid dependence. President and CEO of Braeburn Pharmaceutical, Behshad Sheldon, noted that the treatment for opioid addiction should be similar on how doctors treat chronic and other serious diseases. He also pointed out that 78 people die each day in the US because of opioid addiction.

Sheldon noted that Probuphine is the first preferred drug to be used but he is still hopeful that they can produce more innovative drugs that can treat this disease.  He also shared his gratitude for the people who made this thing possible. He thanked the patient, NIDA and the investigators for their support in helping them to reach this far.

The commonly prescribed medication for opioid dependence is Buprenorphine. It is available in sublingual or oral formulation. Probuphine was prioritized in the review because it has a potential to reduce accidental exposure particularly to the pediatric population.

According to Richard Rosenthal, Medical Director of Addiction Psychiatry at Mount Sinai Behavioral System and Professor of Psychiatry at Icahn School of Medicine at Mount Sinai, Probuphine is the first drug to treat opioid dependence that provides a solid evidence-based medicine. This drug offers the clinically stable patient another way to continue their medicine with the assurance that the dose that they take is the amount prescribed to them.

Indications for Using Probuphine

Only those patients who had a clinical stability for low to moderate dose of transmucosal buprenorphine with not more than 8 mg per day are advice to take the maintenance treatment for opioid dependence. It is also indicated that patients should have an additional psychosocial and counseling support to complete the treatment.

Probuphine was developed utilizing ProNeura, a Titan Pharmaceutical drug delivery system which consists of a solid and small implant made from ethylene-vinyl acetate and another drug substance. It is placed subdermally, in an out-patient procedure.  It is removed at the end of the treatment period.

The implant is about the same size as the matchstick. The implant contains an equivalent dose of 80 mg of buprenorphine.  It is placed under the skin at the inner side of the upper arm.

The probable side-effects of probuphine is similar to those seen in buprenorphine.  From the clinical trial, the systemic side effects include insomnia, headache, nausea, upper respiratory infection, back pain, anxiety, constipation, vomiting and depression. More so, the implant site reaction includes swelling, redness, itching and pain.

Other side-effect of the implant may include expulsion, protrusion, migration and nerve damage which are associated with insertion or removal of the implant.

Kelly J. Clark, President Elect of the American Society of Addiction Medicine, commented that, for the last 15 years, there was no concrete step to address the issue of lack of other treatment options. Clark is appreciative for the Secretary of Health and Human Services and also the President for extending their strong support to the fast approval of this drug. Clark shared that opioid dependence affects people from all walks of life. It is about time that people will take an action to reduce the prevalence of this life-threatening disease.

Patient’s Welfare Comes First

Probuphine’s approval will be beneficial for patients because aside from the therapeutic effect, patients can decide what form of treatment will be best for them. Having more treatment options means more freedom to seek what treatment is more favorable for them.  This approval will encourage biotech companies to become more innovative in creating new drugs.


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