A new diet pill Contrave got approval to be sold in the United
States on Wednesday, only the third obesity treatment in more than a decade to
win approval from the Food and Drug Administration. Made by Orexigen
Therapeutics Inc, Contrave is a combination of the antidepressant bupropion and
Orexigen's formulation of naltrexone, designed to prevent drug dependence.
Because Contrave contains an antidepressant, it will carry a warning about
increased risk of suicidal thoughts and behaviors. Contrave joins Vivus Inc's
Qsymia and Arena Pharmaceuticals Inc's Belviq, both approved in 2012, in the
battle to be the treatment of choice and at least one analyst expects the new
entrant's sales to top that of its rivals by 2016.
"For all the obesity drugs that are out
there, only 30 to 40 percent of the health maintenance organizations pay for
obesity coverage," said Daniel Lang, analyst on RS Investments' Value
Fund, which holds a stake in all three companies. Historically, weight loss
drug developer's have met with regulatory ire, as debilitating side effects
associated with their pills led to their forced removal.
Regulatory submissions are the most decisive
milestone drugs like these. Quality regulatory document submissions can
speed-up the time to market a drug, bring the advantage of new treatment to
patients, and conserve patent life.
At Turacoz Healthcare
Solutions, Our team of medical writers have a clear understanding of
the global regulatory requirements/expectations and International Conference on
Harmonization (ICH) Good Clinical Practice (GCP) guidelines. Our medical
writers are experienced in delivering protocols, investigational brochures,
clinical study reports, and documents for IND and NDA submissions.
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