Home » HEALTH » FDA Panel Approves Female Viagra ‘Flibanserin’ Finally, What Next?

FDA Panel Approves Female Viagra ‘Flibanserin’ Finally, What Next?

The Food and Drug Administration (FDA) panel recommended approval of flibanserin, the female Viagra, by a vote of 18-6, with riders associated with the approval, prompting many women organizations to welcome the move despite the risks associated with it. The male equivalent has as many as 25 drugs for sexual dysfunction and with this they hope to achieve gender equality.

However, before prescribing it, doctors may be asked to brief their patients with the possible side effects such as dizziness, nausea, and fainting.Image result for viagra

Even physicians will be asked to obtain a certification from the authorities before prescribing it, such as not taking alcohol before taking the pill, not to drive vehicles after taking the pill, not to take along with moderat e-to-strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, clarithromycin, ciprofloxacin, diltiazem, erythromycin and fluconazole.

The approval came in the wake of a fight by women’s organisation under the umbrella of “Even the Score” for delaying or denying the approval since 2010. After rejecting the approval twice, the FDA panel approved the proposal of flibanserin drug with due clinical trials.

Developed by Sprout Pharmaceuticals, the female Viagra will see final approval by August 2015, said ABC News4.

However, many FDA panel members were reluctant to give the approval and made it compulsory to list the side effects and benefits to the consumer and doctors before selling it in the market, said reports.

Flibanserin efficacy study results showed that of a total sample of 1,227 patients who received flibanserin 100 mg qhs and 1,238 received placebo in the three pivotal studies on premenopausal women with a primary diagnosis of HSDD.

In the initial pivotal program, flibanserin demonstrated statistically significant superiority to placebo on only one of two co-primary endpoints, and regarding improvements in desire, flibanserin showed separation from placebo on both eDiary Desire (primary) and FSFI-Desire (secondary) but that difference reached statistical significance only for the secondary endpoint, said a report by the FDA.

Based on the recommendations of FDA advisory committee, Sprout Pharma has completed an additional pivotal study (Study 147), using a validated instrument for measuring desire (FSFI-Desire) as the primary measure of change in sexual desire. “This study demonstrated statistically significant improvement on both that endpoint and the co-primary endpoint, change in SSEs,” said the report.

However, before prescribing, the doctors should counsel their patients on the following score points:

PATIENT COUNSELING TOPICS

FLIBANSERIN is a central nervous system depressant and may cause somnolence. Patients may experience impaired judgment, thinking or motor skills. Patients should be cautious about operating hazardous machinery, including automobiles, until they know how FLIBANSERIN affects them.

FLIBANSERIN may cause syncope (fainting), dizziness and/or hypotension (low blood pressure). The side effects associated with FLIBANSERIN may be intensified by taking FLIBANSERIN and consuming alcohol or taking another CNS depressant.

Patients should avoid drinking alcoholic beverages until they know how FLIBANSERIN affects them. The side effects associated with FLIBANSERIN may be intensified by taking FLIBANSERIN during waking hours or exceeding the indicated dose.

FLIBANSERIN is contraindicated for use with moderat e-to-strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, ciprofloxacin, diltiazem, erythromycin and fluconazole). Patients should contact your office if they experience a side effect that continues to bother them.

Patients should take FLIBANSERIN at bedtime. Patients should not drive or engage in other activities requiring full alertness until the morning after taking FLIBANSERIN. If a dose is missed patients should not take the missed dose the next morning or double the next dose.

Patients should skip the missed dose and resume routine dosing the next night. Patient response to FLIBANSERIN varies. Instruct patients to contact your office if they experience inadequate response after 12 weeks of treatment. This will allow you to in evaluate whether therapy should be discontinued.

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