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Teva Pharmaceuticals Halts Nuvigil Clinical Trials

Staff Writer3 years ago

After its phase III trial failed to prove it was any more effective at treating major depression associated with bipolar disorder, Teva Pharmaceutical Industries Ltd. Has halted development of Nuvigil (armodafinil).

Teva Pulls Out of Regulatory Filings for Nuvigil

“While this study demonstrated a numerical improvement, we are disappointed that armodafinil did not reach statistical significance. Teva remains committed to advancing science in serious conditions affecting the central nervous system. We will continue to focus on our current Nuvigil indications and we remain committed to improving wakefulness in adult patients with excessive sleepiness associated with shift work disorder, obstructive sleep apnea or narcolepsy.” – Dr. Michael H. Hayden, Teva's CSO and President Global R&D as published by the Wall Street Journal

  • Nuvigil is a drug used to treat excessive sleepines and narcolepsy. According to the Wall Street Journal, the clinical trials being conducted by Teva sought to gain FDA approval for the drug to be used as a treatment major depression associated with bipolar I disorder.
  • Teva Pharmaceuticals claimed all of their studies, up to and including their Phase III trial, showed significant improvements in their patients' responses. However, after an evaluation of the overall results from their trials, the company decided it would not go forward with regulatory filings for Nuuvigil.
  • Their spokesman claimed, “There is no material impact to the company.”

Possible Side Effects of Nuvigil

  • Nuvigil’s website warns of possible side effects, including depression, anxiety, sensory dysfunction, manic activity, suicidal thoughts, aggression or other mental problems.
  • Heart problems like chest pains, an abnormal heart beat and trouble breathing can also be a result of taking Nuvigil.
  • More common side effects include headache, dizziness, trouble sleeping and nausea.
  • This is not an all-inclusive list and, if you are currently taking Nuvigil and experience any of the above adverse effects or other abnormal feelings, you should contact your doctor immediately.
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