Mental Health Disorders

FDA Roundup: New Options for Depression, Schizophrenia, Lung Cancer

Rexulti – Depression, Schizophrenia

The FDA has approved Rexulti (brexpiprazole) tablets for the treatment of schizophrenia and for the treatment of major depressive disorder (in combination with antidepressants.)1

The safety and effectiveness of Rexulti for the treatment of schizophrenia was evaluated in a study of 1310 participants in 2 6-week trials, in which the drug was shown to reduce the symptoms of schizophrenia compared to placebo.

The effectiveness of Rexulti in treating depression was evaluated in 2 6-week trials including 1046 participants in which Rexulti plus an antidepressant were compared to placebo plus an antidepressant. Rexulti effectively reduced the occurrence of depression symptoms compared with placebo.

The most common side effects reported with Rexulti were weight gain and restlessness.
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Iressa – Metastatic Non-Small Cell Lung Cancer

The FDA has approved Iressa (getfitinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with tumors harboring particular gene mutations.2

Iressa, a kinase inhibitor, works by blocking certain proteins that promote growth in cancerous cells with certain epidermal growth factor receptor gene mutations.

The safety and efficacy of Iressa was evaluated in a multi-center, single-arm clinical trial of 106 patients with untreated NSCLC with the appropriate gene mutation. Participants were given 250 mg of Iressa once daily. Roughly 50% of participants experienced tumor shrinkage, and the effect was shown to last an average of 6 months.

Researchers also conducted a retrospective analysis of data from another clinical trial in which 186 participants were randomized to receive either Iressa or up to six cycles of carboplatin/paclitaxel. Results suggested that Iressa benefited progression-free survival.

Serious side effects include interstitial lung disease, liver damage, gastrointestinal perforation, and ocular disorders. The most common side effects include diarrhea and skin reactions.

—Michael Potts

References:

  1. FDA. FDA approves new drug to treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm454647.htm. July 13, 2015.
  2. FDA. FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm454678.htm. July 13, 2015.