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Sprout Pharmaceuticals 6 articles

Valeant, Sprout announce partnership days after approval of so-called female Viagra

Two days after Sprout Pharmaceuticals Inc. made history by becoming the first drug company to gain approval for a so-called female Viagra pill, Valeant Pharmaceuticals International Inc. announced that it would be shelling out $1 billion in cash to buy Sprout. Sprout’s drug flibanserin, which will be sold under the brand name Addyi, is designed to treat low sexual desire in premenopausal women. The drug was approved amid controversy that included skepticism from researchers that the drug actually worked, and women’s advocacy groups that argued drug regulators were more reluctant to approve a sexual enhancement drug for women despite there being several ... Read More

FDA advisors recommend approving first-ever ‘female Viagra’

A “female Viagra” pill has gotten a nod by Food and Drug Administrator (FDA) advisors, paving the way for the first approved treatment for lack of sexual desire in women. The FDA will make the final decision whether to approve the drug for marketing. The agency is not required to follow the recommendations of its advisors, but it usually does. Filbanserin, which would be marketed as Addyi if approved, has been rejected two previous times by FDA panels based on efficacy doubts and side effects concerns. Analysts were quick to raise doubts whether the additional data provided by drug maker ... Read More

FDA advisors raise concerns over ‘female Viagra’ during third review

The Food and Drug Administration (FDA), for the third time, is raising concerns about safety risks with the so-called female Viagra drug currently under review. The agency says the drug can cause women to faint and accidentally injure themselves, especially if the medication is taken with alcohol. The concerns were published on the FDA’s website two days before an FDA advisory panel will decide whether to recommend approval of the drug or, for the third time, reject it based on concerns. The FDA is not required to follow the recommendations of its advisory panels, but it usually does. The drug ... Read More

FDA to take a third look at safety, effectiveness of female Viagra

Sprout Pharmaceuticals is resubmitting its so-called female Viagra in hopes of gaining approval from drug regulators despite two previously failed attempts at approval based on safety concerns. If approved, the drug, fibanserin, would be the first medication designed to boost female libido to hit the market. Drug makers have been working for years to develop a drug to help women who lack sexual desire ever since the blockbuster success of Viagra for men. Sprout’s previous attempts at Food and Drug Administration (FDA) approval were squashed due to questions about effectiveness and concerns about side effects such as fatigue, dizziness and nausea. The ... Read More

Drug company to seek FDA approval for first ‘female Viagra’

Sprout Pharmaceuticals says it will resubmit an application for Food and Drug Administration (FDA) approval for its “female Viagra” pill by the end of the year in hopes of having the first marketed pill to treat hypoactive sexual desire disorder, or HSDD, in women. HSDD is the most commonly reported female complaint and is characterized by a decreased libido that causes personal distress or personal difficulties. An estimated 1 in 10 women are affected by the disorder. Filbanserin is a 5-HT1A receptor agonist and 5-HT2A receptor antagonist that was initially investigated as an antidepressant. Preclinical studies suggest that fibanserin targets ... Read More

FDA rejects another drug aimed at increasing female libido

The decades-long search for a female equivalent to the libido-boosting drug Viagra for men will not be filled any time soon. The latest drug candidate, Sprout Pharmaceuticals’ filbanserin, was rejected by the Food and Drug Administration (FDA). The agency questioned whether the drug’s benefits – which it said were “modest” at best – outweighed the potential side effects, which include fatigue, dizziness and nausea. Developing drugs to boost female sexual desire is a complicated science because the root cause can be multifaceted – such as psychological – and thus harder to understand and measure. “And, quite honestly, we don’t know enough about ... Read More