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FDA: New Options for Opioid Dependence, MS, Prostate Cancer

Probuphine: Opioid Dependence

The US Food and Drug Administration (FDA) has approved the first buprenorphine implant, Probuphine, for the treatment of opioid dependence.

Although buprenorphine already is approved in the form of a pill and an oral film, the implant provides a constant low dose of buprenorphine for 6 months in patients already on low to moderate doses of buprenorphine.
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To determine the safety and efficacy of Probuphine, researchers conducted a randomized, clinical study of adults who met the clinical criteria for opioid dependence and were stable after prior buprenorphine treatment.

The results showed that 63% of adults treated with Probuphine had no evidence of illicit opioid use during the 6 months of treatment; similarly, 64% of those treated with the sublingual buprenorphine alone were opioid-free for 6 months.

The most common adverse reactions reported were implant-site pain, itching, and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain.1

Zinbryta: Multiple Sclerosis

The FDA has approved Zinbryta (daclizumab)—a self-administered, long-acting monthly injection—for the treatment of adults with relapsing forms of multiple sclerosis (MS).

In a clinical trial of 1841 patients with MS, researchers found that patients taking Zinbryta had fewer clinical relapses than patients taking interferon beta-1a after 144 weeks. The most common adverse reactions reported were nasopharyngitis, upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal pain, eczema, and enlargement of lymph nodes

Another trial of 412 patients with MS found that patients taking Zinbryta had fewer relapses than those taking placebo after 52 weeks. The most common adverse reactions reported were depression, rash, and increased alanine aminotransferase.

The FDA warns that Zinbryta should only be prescribed for patients who respond inadequately to 2 or more MS drugs, because it has serious safety risks, including liver injury or immune conditions.2

Axumin: Recurrent Prostate Cancer

Axumin, a radioactive diagnostic agent for injection, has been approved to treat recurrent prostate cancer. It is used in positron emission tomography scans in men with suspected recurring prostate cancer based on elevated prostate specific antigen (PSA) levels following prior treatment.

In 1 study, onsite radiologists and 3 independent radiologists compared 105 Axumin scans with the histopathology of prostate biopsy and biopsies of suspicious imaged lesions. They determined that Axumin was safe and effective for imaging recurrent prostate cancer.

In another study, onsite radiologists and the same 3 independent radiologists from the first study evaluated the agreement between 96 Axumin and C11 choline scans in men with a median PSA value of 1.44 ng/mL. The independent radiologists confirmed the onsite radiologists’ findings and determined Axumin was safe and effective for imaging recurrent prostate cancer.

The most commonly reported adverse reactions in patients were injection-site pain, redness, and a metallic taste in the mouth.3

—Amanda Balbi

References:

  1. Peddicord S. FDA approves first buprenorphine implant for treatment of opioid dependence [press release]. Silver Spring, MD: US Food and Drug Administration; May 27, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503719.htm. Accessed May 31, 2016.
  2. Walsh S. FDA approves Zinbryta to treat multiple sclerosis [press release]. Silver Spring, MD: US Food and Drug Administration; May 27, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504000.htm. Accessed May 31, 2016.
  3. Kelly C. FDA approves new diagnositic imaging agent to detect recurrent prostate cancer [press release]. Silver Spring, MD: US Food and Drug Administration; May 27, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503920.htm. Accessed May 31, 2016.