By Natalie Morrison; Additional reporting by Jennifer C. Smith-Parker
Sexual liberation for women or sexism gone mad? The approval of Sprout Pharmaceuticals and Valeant Pharmaceuticals' female sexual dysfunction (FSD) drug, Addyi, has attracted comments at both extremes and everything in between.
In any case, nicknamed the "female Viagra" by many, it seems the twice FDA-rejected little pink pill's mechanism is poorly understood. Unlike Viagra, which stimulates a physiological reaction in men as and when is needed, Addyi is a psychological therapy that promotes desire for women.
The drug will not work in women who do not genuinely have hypoactive desire disorder (HSDD), a psychological condition that causes loss of sexual desire and increased distress during sexual activity, doctors told BioPharm Insight. (And no romantic wining and dining pre-event, as women are advised not to drink alcohol with Addyi or risk side effects such as lowered blood pressure and fainting.)
Just 7% of premenopausal women in the US are believed to have HSDD, and doctors do not anticipate it will work for all of them. Cindy Whitehead, the CEO of Sprout -- the company that took Addyi through FDA approval before Valeant bought it for a hefty $1 billion -- said 43-60% of women experienced positive change in sexual desire in a Phase III trial.
Meanwhile, erectile dysfunction happens on a regular basis to around 1 in 3 men over 55 and -- for those with no contraindications who can tolerate the side effects such as headaches -- Viagra generally works.
So why the big uproar over Addyi?
Besides being the first FSD drug to receive FDA’s stamp of approval, Addyi has raised controversy among some ob-gyn doctors in the press who insist it is not efficacious enough and was approved only because the FDA bowed to pressure from women's rights groups. In clinical trials, the drug induced 1.5 more sexually satisfying events (SSEs) per month on average, which some say is not enough.
Yet, other doctors argue the idea is only to restore women's libido, not to make them hyper sexual beings, and so 1.5 additional SSEs per month on top of any other SSEs patients may have naturally is adequate. Furthermore, those who respond well to the drug can see 4, 5 or more additional SSEs, investigators on late stage clinical trials said.
As with any newly approved therapy, particularly one in a previously untreated patient population, Addyi's effect in real-life will be revealed in time as more scripts are filled.
However, and most importantly for business brains, what will also be proven with time is whether Valeant's bold $1 billion purchase of Sprout was genius or over-zealous.
Addyi's peak sales figures have been predicted anywhere between $100 million to $300 million, which makes the $1 billion price tag seem rather expensive.
So the question, is: Did Valeant jump in with both feet to snap up a "female Viagra" that simply won't live up to its so-called male counterpart, or is the market outlook sunnier than this bleak forecast?
It seems, at least at first, Addyi will face an uphill struggle to get US insurers to pay up. Sprout issued estimates of Addyi as a Tier 2 or 3 therapy akin to Viagra pricewise, with a $35 to $75 co-pay. Yet, US health insurance experts say Tier 2 is unattainable, at least at first, especially with its debated clinical efficacy and safety warnings. It is likely the drug will stay off many formularies for at least 3 - 6 months, other experts said.
If reimbursed, the drug will come with heavy Risk Evaluation and Mitigation Strategy (REMS) baggage, and physicians will need to be so sure it is effective that they would be willing to stick their neck out and explicitly state why it is necessary for their patient.
Public reports claim that without help from insurers, women would have to pay as much as $400 per month for access.
In any case, reimbursement experts and doctors alike agree Medicaid is unlikely to wade in.
So, for now at least, Addyi is strictly out of the grasps of women on lower incomes, leaving the little pink pill firmly for the middle and upper classes. Whether middle class usage alone will foot the bill for Valeant is yet unknown.
Senior Reporter Natalie Morrison is based in London and covers allergies, men's and women's health as well as overall business development and the services sector for BioPharm Insight. She can be reached at NMorrison@eu.biopharminsight.com. Assistant Editor Jennifer C. Smith-Parker, also in London, covers the regulatory and reimbursement landscape as well as biosimilars and orphan diseases. She can be reached at JSmith@eu.biopharminsight.com.
This post is brought to you by BioPharm Insight, a product of Infinata, part of The Mergermarket Group, delivering exclusive news, predictive intelligence and analytics on drug development and market uptake.
