In a massive, chart-laden 300-plus page report, executives at Raleigh-based Sprout Pharmaceuticals promise to launch what has been called a “female Viagra” drug with a low-key marketing campaign that stresses safety should the FDA approve it.

Just ahead of a hearing today in Washington, D.C. where experts will discuss the pros and cons of approving the drug flibanserin that is intended to treat hypoactive sexual desire disorder (HSDD) in premenopausal women, Sprout made numerous pledges in a briefing document in an attempt to allay concerns about its safety.

“There is great need for a proven, safe, and properly labeled medication that provides meaningful and quantifiable benefits to HSDD patients,” the Sprout executives wrote.

However, the FDA has rejected flibanserin in the past, and Sprout in response launched additional clinical research in its attempt to document effectiveness as well as safety. Sprout filed for FDA approval again in February, setting the stage for today’s hearing.

Should Sprout win backing at today’s hearing in Washington, FDA approval could come in the near future.

If the FDA goes along, Sprout said product launch would not include a barrage of commercials on TV and in print such as those often used by drug firms selling male-related drugs.

“Pressure” for prescriptions

“Recognizing that specific patient requests for a new drug may put pressure on prescribers, upon approval of flibanserin the Sponsor [Sprout] plans a focused product launch, without use of direct to consumer television and radio advertising of flibanserin for at least 18 months, with a concerted educational effort for prescribers in order to ensure a clear understanding of the appropriate population for flibanserin treatment,” the company said in the document.

Under a section titled “Risk Management ,” Sprout stressed that it would warn physicians and patients about making sure the drug is used safely.

“The Sponsor has developed a comprehensive risk management program to ensure safe use of flibanserin,” the company said.

Six safety points

Key points include:

• “Instructions to stop treatment if adequate clinical response is not achieved by 12 weeks

• “Explicit instruction to avoid daytime dosing or double dosing

• “A contraindication for use with moderate to strong CYP3A4 [ Note: CYP3A4 is an enzyme that “metabolizes about half of all drugs on the market,” according to Pharmacy Times.]

• “A warning regarding alcohol use

• “Clear language about the potential risks of sedation, dizziness, hypotension and syncope

• “An indication statement also reinforces that flibanserin should not be used for any sexual dysfunction other than HSDD”

“Mitigation activities”

Sprout added that a “Medication Guide” would include “the key risks, necessary precautions and mitigation activities in non-professional language designed for patient comprehension.”

The plan includes what Sprout calls “clear, patient-friendly language” about “bedtime dosing, avoidance of driving until the next morning, discontinuation of therapy if an adequate response is not achieved, avoidance of alcohol until flibanserin’s effects are understood and the importance of disclosing other medication use.”

Sprout also plans to offer a “training slide deck” for guidance to doctors.

“Health care professional (HCP) training will focus on flibanserin’s safety profile and appropriate patient selection. Training will be distributed by the Sponsor’s field personnel and Medical Information Department, and will be available on t he flibanserin brand website,” the company said.

“By presenting appropriate use and safety messages through a different vehicle, physician training provides an additional avenue for reinforcement of those messages.”

Sprout also said the company would monitor physician and patient “knowledge, attitudes and behaviors” on a regular basis “through multiple measurement tools. Prescribing information will also be mined to assess prescribing and dispensing behaviors related to age (as a rough indicator of menopausal status), bedtime dosing instructions, and drug-drug interaction information.”

The full document can be read online at: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/drugsafetyandriskmanagementadvisorycommittee/ucm449090.pdf