But the basis of lawsuit is fraught with questions. Valeant stands to make 60 percent of any profit from all sales of Addyi and took on huge financial risk when it made the $1 billion purchase from Sprout. So the question is, why would it try to limit Addyi’s success?
The Addyi Lawsuit in a Nutshell
The investors behind the lawsuit were the same ones that backed Sprout Pharmaceuticals in developing the female libido pill. Valeant merged with Sprout and bought Addyi for $1 billion right after the U.S. Food and Drug Administration’s controversial 2015 approval of a drug many believe has more risks than benefits.
The former investors recently filed the suit against Valeant on claims that the company is failing to market the female libido pills successfully. Specifically, they’re blaming Valeant for:
- Exorbitant pricing on the drug (a cost to patients of $800 per week), which joins a chorus of complaints from critics who question the company’s pricing policies
- Drastically reduced profits because Addyi may generate less than $10 million this year, which would be far less than what the parties hoped for
- Former investors will be shortchanged in result of poor profits – losing anticipated millions of dollars.
Valeant, which has U.S. headquarters in Bridgewater, N.J., denies it has done anything wrong regarding Addyi.
“Simply put, Addyi is languishing because of Valeant’s operational ineptitude and breach of its obligations under the merger agreement,” says the complaint filed in November 2016 in Delaware Chancery Court by Shareholder Representative Services.
Valeant responded to the suit, stating that the merger agreement, “certainly does not require Valeant to follow Sprout’s business plan” and “entitles Valeant to use its own discretion in marketing and commercializing Addyi. Valeant’s $1 billion investment in Addyi provides it with more than sufficient incentive to make the drug successful.”
Bloomberg reports that investors also claim that Valeant predatorily priced Addyi at double the cost that Sprout had established as successful price point, based on extensive market research. They claim that the result of the pricing decision was that insurance companies refused to cover the drug, making it not affordable for millions of women.
According to Bloomberg, Sprout investors wrote Valeant on March 14 to challenge the company’s marketing of Addyi. Investors also wanted proof that Valeant will still follow through on its promise to spend $200 million on Addyi marketing during the first half of 2017.
They also want Valeant to confirm that it will not reduce its 150 rep sales force that sell Addyi despite the slow sales. In a statement, Valeant spokeswoman, Laurie Little, said the company intends to comply with all of its obligations under its agreement with the former Sprout shareholders, including as they relate to marketing spend, number of sales reps, and post-marketing studies.
The Challenges of Marketing Addyi
Addyi (flibanserin) 100 mg tablets, developed by Sprout Pharmaceuticals, was FDA-approved on August 18, 2015, for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Along with long-awaited FDA approval for Addyi, the agency also placed a black-box warning on the drug, which warns about side effects and the drug’s overall safety, plus requires the company marketing it to conduct follow-up studies.
There are reported side-effect when using Addyi. Most common was a feeling of dizziness or fainting. One in five women involved in the initial drug 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: Fainting or loss of consciousness can happen when you take Addyi even if you do not drink alcohol or take other medicines or herbal supplements. This is also why you take it at bedtime. Your risk of low blood pressure and fainting (loss of consciousness) is increased if the medication is taken during waking hours, if you drink alcohol, or if you take certain medicines or herbal supplements.
- Take certain prescription or over-the-counter medicines, or herbal supplements: Do not take or start taking any new prescription medicines, over-the-counter medicines, or herbal supplements while taking Addyi until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking this prescription.
- Have liver problems: You should not take Addyi if you have been diagnosed with liver problems.
In contrast to many patient accolades, there has also been a publicized study that claims improvements experienced by women taking the medication were minimal.
But, clinical trial data from Sprout Pharmaceuticals, found that 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.
Will Addyi Survive?
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.
About 40 percent of women in the U.S. experience some form of female sexual dysfunction, ranging from mild to severe. One specific type, which impacts premenopausal women, is hypoactive sexual desire disorder (HSDD). 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.
Though Addyi is called the “female Viagra”, it actually works very differently. 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.
In contrast, Addyi addresses three key chemicals in the brain which are connected to expected/natural sexual response. It works by increasing dopamine and stimulates certain receptors in the brain while blocking others.
Valeant says it’s still committed to Addyi, and its reps will be actively working to educate providers about the drug. So, Addyi will continue to be available to consumers.
Addyi can be bought through your local pharmacy, or you can order it online through a reputable online store so that your privacy is protected and it is delivered discretely. Other benefits of ordering online include convenience; meaning you don’t need to make a special trip to your pharmacy to pick it up.
If ordering online be certain that your prescription comes from an FDA-licensed distributor located in the United States. Since 1998, eDrugstore.com has helped more than 500,000 customers gain access to prescription medications for male impotence, while offering first-class customer service and support.
We specialize in providing our over 1,000,000 customers with relevant product and condition information created by our professional editorial staff which includes our team of medical writers, medical practitioners, and health educators. eDrugStore.com Staff on Facebook