Contrave, a new medication for weight loss produced by Orexigen Therapeutics, is being tested. This further study was recommended by the Food and Drug Administration (FDA) after the pharmaceutical company submitted the New Drug Application (NDA).
Many studies have already been done to test the drug against a placebo sample population to see its effects on healthy, non-diabetic, obese patients. They have confirmed that the drug, specifically naltrexone plus bupropion, could be an effective treatment to tackle obesity in patients that are found to be appropriate for the medication. However, the FDA has requested the light study to further assess patients’ risk of cardiovascular diseases or complications.
This light study, started in June 2012, will show whether the benefit-risk outline of the medication will be changing or constant. In other words, whether the cardiovascular risks that may be associated with the medication override the weight loss benefits or vice versa. An interim analysis is due to be organised and afterwards, the company is planning on resubmitting its NDA to the FDA.
Takeda has partnered with Orexigen to market the medicine in Mexico, Canada and the United States. Hence, the medication is expected to be available in those countries soon after the FDA approval.
The most common side effect that has been reported by patients in earlier studies was mild to moderate nausea. If you are considering trying this medication, if eventually approved, we recommend a full research on the possible side effects of the drug, and a full consultation with your doctor.
Just a couple of days ago Orexigen Therapeutics declared that, within the next few months, they will be able to have more data on major adverse cardiovascular events (MACE). They believe this new data will be sufficient to start the interim analysis. The pharmaceutical company predicts to be able to send the new NDA to the FDA by the end of the current year.
Furthermore, the company has announced that it is planning on submitting the Marketing Authorisation Application (MAA) for the new medication before the start of the interim analysis. The body that will receive the application will be the European Medicines Agency (EMA). However, data detailing the cardiovascular outcomes will be available to the Committee for Medicinal Products for Human Use (CHMP).
We will keep you posted on the situation and update you on any new outcomes.