Med Check

Participants in a joint meeting of the Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee and its Drug Safety and Risk Management Advisory Committee in June voted 14-3 not to recommend the approval of Remoxy ER (oxydone extended-release capsules) for the management of severe pain.

Remoxy ER, made by Pain Therapeutics Inc., is a high-viscosity gel formulation designed to keep people from being able to cut, grate, or inject the drug. Some committee members suggested that data presented on the efficacy, safety, and risk-benefit profile of Remoxy ER did not support approval of its application, especially regarding claims of abuse deterrence.

Sage Therapeutics in June announced its expedited development plan for its lead compound SAGE-217 following a meeting with the FDA. SAGE-217, a drug that targets the GABA-A receptor, received FDA breakthrough status in February for the treatment of major depressive disorder (MDD).

The new plan includes expedited approval pathways for SAGE-217 for both MDD and postpartum depression (PPD). An ongoing phase 2 study comparing depressive symptoms in women with PPD who receive either 30 mg SAGE-217 or placebo for two weeks was confirmed as appropriate to support registration for PPD, the company noted. The FDA also requested n additional phase 3 trial for MDD. The trial will compare outcomes in 450 patients who take SAGE-217 (20 mg or 30 mg) or placebo for two weeks.

Sage will also begin a one-year open-label study of patients with major depression to acquire additional safety data and evaluate the long-term effectiveness of two weeks of SAGE-217 for recurrent major depressive episodes.

In June, the diagnostics company Saladax Biomedical Inc. signed a license agreement with Janssen Pharmaceutical NV—one of the Janssen Pharmaceutical companies—to acquire exclusive patent rights for diagnostic blood tests that can determine drug levels in patients undergoing treatment with antipsychotic medications.

“This intellectual property, along with the existing patents that Saladax already owns, places Saladax in a predominant position in the field of antipsychotic drug testing,” according to a press release by the company.

Saladax in March received approval to sell two of its diagnostic tests on the European market: the MyCare Total Risperidone Assay Kit and MyCare Paliperidone Assay Kit. The company has four additional tests for aripiprazole, clozapine, olanzapine, and quetiapine that it expects will receive European clearance later this year. Saladax stated the company will soon seek FDA clearance for these tests as well.

The American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine, and American Society of Anesthesiologists recently joined together to develop consensus guidelines on the use of intravenous ketamine to treat both chronic and acute pain.

These guidelines, published in the journal Regional Anesthesia and Pain Medicine in June, cover a range of scenarios, but broadly state that moderate evidence supports the use of ketamine for acute pain management following painful surgeries, including in people who are opioid dependent. There is also moderate evidence that ketamine works for chronic spinal pain and complex regional pain syndrome. There is limited evidence to support ketamine for other types of chronic or acute pain.

The guidelines noted that ketamine should be avoided in people with poorly controlled cardiovascular disease, those with active psychosis, and pregnant women. ■