Will the ‘Female Viagra’ Experience Change How the FDA Approves Drugs?

Recently, two drug manufacturers, who had developed two very different kinds of drugs, pushed the FDA for approval – and got it. 

Female sexual arousal disorder and Duchenne muscular dystrophy (DMD) do not have anything in common – except that recent FDA-approved drugs to treat these conditions are under scrutiny. Some medical experts are saying that the FDA succumbed to the public pressure put on them and that the review process must be revised.

The Drugs that Shook Up the FDA Approval Process

FDA scientists thought studies designed to test the safety of Exondys 51, the drug that is now prescribed to treat  Duchenne Muscular Dystrophy (DMD), was flawed in determining the risk of side effects and overall effectiveness. 

Addyi, the “sometimes called female Viagra” was actually rejected by the FDA in 2010 and 2013 and the National Women’s Health Network also gave the drug “D”s, “F”s and “I”s–for “incomplete”–on a report card assessing its first-year performance. 

But, in contrast, many women who suffer from low libido claim that taking FDA approved Addyi, also called “the little pink pill,” provided notable improvement to their levels of sexual desire. Despite the patient accolades, some studies suggest that improvements from taking the medication were minimal.

Now, the approval of these drugs and the questions surrounding their safety versus their value to a patient’s health is raising concerns about the FDA. The argument suggests that public pressure, versus strong scientific evidence, is behind some medications hitting the market. This has put the FDA approval process under scrutiny and changes may be forthcoming.

A Closer Look at the FDA

The FDA has taken a closer look at their approval process. It recently drafted a 15-page “draft guidance” on developing drugs for the treatment of “low sexual interest, desire and/or arousal in women.” 

Cindy Pearson, executive director of the National Women’s Health Network in Washington, D.C., who previously disapproved of the release of Addyi because of questions about effectiveness the risks it posed to those taking it, stated that this is a positive step though it is coming a little too late.

Two recent documents posted to the Food and Drug Administration’s website suggested that the FDA approval process responds to the pleas of patients with female sexual dysfunction and DMD, rather than scientific evidence of effectiveness and safety. If true, the approval process is flawed.

A Closer Look at the Conditions and the Drugs

The two conditions in the spotlight have nothing in common – one is a genetic disease that typically affects boys, causing muscles to deteriorate over time until they die, usually before the age of 30, while the other is a psychiatric diagnosis in women who suffer low libido with no known medical cause.

And Addyi has had its share of concerns in the treatment of female sexual dysfunction. This year, a review of clinical trials concluded that the drug on average resulted in one additional “satisfying sexual event” every two months, but also “statistically and clinically significantly increasing the risk of dizziness, somnolence, nausea and fatigue.”

One study, conducted by a team of Dutch researchers, examined a group of eight separate studies combined, which included the results of about 6,000 women who took Addyi for low libido. The results indicated that Addyi, or flibanserin, provided only a minimal change in the libido of women within their study. 

Some argue that those studies are flawed. Medical director of the Center for Sexual Medicine at Northwestern Memorial Hospital in Chicago, Dr. Lauren Streicher, told CNN that the results cited in the Dutch study are based only on averages. 

This means that while it may be true that Addyi doesn’t work for everyone, many patients, including several Dr. Streicher has prescribed Addyi to, have found it to be very beneficial.

As for the drug Exondys 51, in the FDA review process for approval, only three of 13 members of an advisory committee agreed that the scientific evidence showed it to be effective. 

Sarepta Therapeutics, maker of the drug, had apparently conducted a trial of the drug with only 12 participants. The findings showed some minimal, positive lab changes with its use, but the results did not match the patient’s physical disabilities with walking, for example.

However, faced with heartbreaking testimony from 52 patients, parents, advocates, scientists and lawmakers–all but one urging approval of Exondys 51, the drug gained FDA approval.

Revamping the FDA Approval Process 

The FDA is poised for changes. For example, the agency will probably do more to insist that sponsors follow their advice earlier in the research process. Recommendations, like using a larger sample and controls (patients who received a placebo for comparison purposes), within clinical trials are in order.

Four main points made for the future of drug approval from the FDA: 

• The guidance suggests asking women in clinical trials to report signs, side effects and results more often than once per month – for greater detail and accuracy.
• The guidance advises that clinical trials of drugs to treat sexual disorders in women be representative of North American women expected to use the drug.
• The guidance noted that low sexual interest, desire and/or arousal occurs in women who haven’t yet gone through menopause as well as those who have, so safety and effectiveness should be established independently for both groups. However, Addyi developer Sprout Pharmaceuticals sought approval only for premenopausal women (Valeant Pharmaceuticals acquired the drug from Sprout two days after it won FDA approval).
• The FDA’s draft guidance also questions the instrument Sprout used to measure overall sexual function, Pearson pointed out. The FDA says it is unaware of data that adequately establish the validity of the 19-question Female Sexual Function Index for regulatory purposes.

What This Means to Patients

Women who have experienced the benefit of Addyi may be disturbed by the studies that question its medical viability. The good news is the drug is still available by prescription. In this instance, it pays to know all about the medication and discuss the benefits and risks with your doctor. Then, decide if it is right for you.

According to clinical trial data from its makers, Sprout Pharmaceuticals, females who took the Addyi experienced a 53 percent increase in sexual desire in comparison to how they rated their libido before the trials. Most women experienced benefits as soon as four weeks of taking Addyi, over a 24-week trial period.

Facts to Know:

1. Addyi is a women-only libido drug targeted for available for premenopausal women, approved by the FDA that hit the market in fall of 2015.  
2. After more than 16 years of hearing about the life-improving benefits of Viagra, the number one prescribed pill for male sexual dysfunction, women finally were given an option of their own. It is the first prescription medication that targets female sexual dysfunction.
3. Forty percent of women in the U.S. experience some form of female sexual dysfunction, ranging from mild to severe. One specific type, is hypoactive sexual desire disorder (HSDD), affecting nearly 1 in 10 women, according to the National Institute of Health.
4. Addyi (Flibanserin), works by increasing dopamine and stimulates certain receptors in the brain while blocking others. Increased sexual desire typically results from taking Addyi daily for up to a month before you may experience any of the drug’s positive effects.

Side Effects:

One in five women involved in the trial reported extreme fatigue, and the drug can also cause light-headedness or nausea,
dry mouth, and difficulty falling asleep or staying asleep. Dizziness is the primary reason why you must take this drug at bedtime only.
As with most prescribed medication, there are side-effects you should know about. Addyi’s label includes warnings not to take the medication if you:

• Drink alcohol
• Take certain prescription or over-the-counter medicines, or herbal supplements
• Have liver problems

If Addyi is Right for You

Once you have discussed your symptoms with your doctor and other medical causes have been ruled out, your doctor can prescribe Addyi. You can fill a prescription for Addyi through your local pharmacy, or you can order it online through a reputable online pharmacy, so that your privacy is protected and it is delivered discretely.