First Medication Indicated for Mania in 25 Years

Strategic Insights -

Bipolar disorder, affecting over 2 million Americans, has received a major breakthrough in treatment with the indication of Depakote (divalproex sodium) tablets for manic episodes. This is the first medication approved in 25 years for this specific use. Depakote has shown significant improvement in manic symptoms in patients compared to placebo, with a notable patient response observed 10 days after treatment began.

Key Takeaways:

  • Depakote is the first medication indicated for manic episodes associated with bipolar disorder in 25 years.
  • More than 2 million Americans are affected by bipolar disorder, with two-thirds not receiving treatment.
  • Clinical trials showed significant improvement in manic symptoms in patients treated with Depakote compared to placebo.
  • Patient response to Depakote was noted 10 days after treatment began.
  • Common adverse events include vomiting (12%), nausea (22%), somnolence (19%), and dizziness (12%).
  • The rate of discontinuation due to intolerance was not statistically different between placebo and Depakote.
  • Long-term safety data are supported by record reviews involving approximately 360 patients treated with Depakote for greater than three months.
  • Abbott Laboratories, the manufacturer, is a worldwide health care products company employing 50,000 people.

Statistics:

  • Over 2 million Americans are affected by bipolar disorder.
  • 2/3 of those with bipolar disorder do not receive treatment.
  • 12% of patients reported vomiting in clinical trials.
  • 22% of patients reported nausea in clinical trials.
  • 19% of patients reported somnolence in clinical trials.
  • 12% of patients reported dizziness in clinical trials.
  • Approximately 360 patients were treated with Depakote for longer than three months in record reviews.

Sources:

  • PR Newswire
  • Abbott Laboratories (NYSE: ABT)