Valeant Pharmaceuticals International Inc. plans a U.S. relaunch of the struggling Addyi, which is intended to treat low sexual desire in women. The drug works quite differently that its popular counterpart for male impotence, Viagra, which has been part of the challenge in its overall sales success.
Approved in 2015 by the FDA, Sprout shareholders who stood to profit from the drugs success said Addyi’s sales suffered because Valeant didn’t market the drug aggressively enough.
Also impacting sales was the fact that Valeant doubled the price of the drug after purchasing it as part of its 2015 acquisition of Sprout Pharmaceuticals. Investors in the pharmaceutical company claimed that the drug was being over-priced, according to a recent Bloomberg report.
According to reports, the accusations were compiled in a letter from Sprout shareholders, which claimed that Valeant has threatened the commercial success of Addyi through overpricing and by neglecting to market the drug properly- as promised within the merger agreement with Sprout. The group making these claims represented all of Sprout’s shareholders during the period of time (August 2015) when it was sold to the Canadian drug company for $1 billion.
Both Valeant and Sprout had big sales forecasts for Addyi, projecting $1 billion in sales over the first seven quarters of distribution, according to the Bloomberg report. But, Addyi has experienced lackluster interest since its launch last October, and investors are blaming the inflated price as a key factor.
Valeant’s Challenges to Be Addressed
Valeant has been struggling with debt and has positioned Addyi’s relaunch, and that of Neutrasal – used to treat dry mouth – as part of a campaign to launch more than 50 products globally in 2017.
Valeant hasn’t reported exactly how much revenue it hopes to generate from the relaunch. But, Addyi’s floundering sales from last year contributed to the financial challenges Valeant struggles with, with its accounting and pricing tactics under attack and debt troubles looming.
One challenge, for example, is that the company recently reported a fourth-quarter loss and decline in revenues, sending shares down 9.8% in morning trade.
Addyi’s Challenges are Part of the Equation
The acquisition of Addyi was expected to boost Valeant’s share of the marketplace, but challenges ensued.
For example:
1. Addyi’s price was increased, most likely to make up for financial issues Valeant was struggling with.
- Valeant set the price of Addyi at approximately $800 per month, despite the fact that Sprout had already established, through extensive market research that the best price point for the drug should be about $400 a month.
- The group of investors contend that because of this inflated price point, most insurance companies are refusing to cover the drug, which essentially makes it unaffordable for the millions of women who have sought a prescription.
- The overpricing issue is that according to a report in Business Journals at the time of the merger, Spout merged with Valeant in-part because combining resources gave greater ability to make Addyi affordable and more easily accessible to the patient who would benefit from it.
Both Valeant and Sprout had big sales forecasts for Addyi, projecting $1 billion in sales over the first seven quarters of distribution, according to the Bloomberg report. But, Addyi has experienced lackluster interest since its launch last October, and investors are blaming the inflated price as a key factor.
2. The drug has mixed reviews when it comes to effectiveness
- Some women’s health advocates, say Addyi—which was rejected by the Food and Drug Administration twice before its 2015 approval—does not work as well as expected.
- It will not produce instant (one-hour) results like Viagra: While Viagra treats a blood flow or “mechanical” issue required for sex within a male’s penis, the main issue with erectile dysfunction, Addyi, addresses three key chemicals in the brain which are connected to expected/natural sexual response.
- 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.
- It must be taken every day, but those on it aren’t supposed to drink and it’s risky to be on hormonal contraceptives along with the drug, according to the National Women’s Health Network.
Facts to Know About Addyi
About 40 percent of females experience some form of female sexual dysfunction, ranging from mild to severe. One specific type, which impacts premenopausal women, is hypoactive sexual desire disorder. It affects nearly 1 in 10 women, according to the National Institute of Health, making the disorder the most commonly reported form of female sexual dysfunction.
Since the 1998 FDA approval of Viagra, the number one prescribed medication for male impotency, women with sexual dysfunction have been left with few treatment options, personal shame, being told they are simply “depressed” or getting older, and stuck with seeking help through herbal supplements that usually fall short of their claims.
Then came Addyi, offering hope with these claims:
- According to clinical trial data from Sprout Pharmaceuticals, makers of the drug, 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.
- Addyi (Flibanserin), started out as an antidepressant, and works by increasing dopamine and stimulates certain receptors in the brain while blocking others. Because of this, taking herbal supplements with it is not recommended and should be discussed with your doctor.
- Addyi is an oral medication that could not be simpler or more convenient to use. You take your dose regularly at bedtime, and can expect to see initial benefits within the first four weeks. But, it may take up to eight weeks to feel the full effect of this medication.
What Happens Now
A Bloomberg report states that the investors who backed Addyi want answers and requested documented materials that prove that Valeant can fulfill its obligations that were promised within the merger agreement with Sprout. The relaunch of Addyi is probably part of the efforts to make good on those promises.
The relaunch provides needed evidence that Valeant is conforming to the merger agreement, with strategic plans in place for a $200 million for marketing, research, and development campaign for 2017.
Valeant has responded to the investor claims stating that it is continuing to work closely with pharmacists, healthcare providers, and patients to educate them about the drug.
The company recently conducted an awareness campaign about female sexual difficulties with the American Sexual Health Association called “Find My Spark.”
Easier Ways to Fill a Prescription
Once you have a prescription for Addyi, it can be bought through your local pharmacy, or you can order it online from a reputable online store. Purchasing prescription medications, like those for Male impotence, via an online pharmacy protects your privacy and ensures products are delivered discretely.
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