In March, just one month after
That’s a tall order for Merck, which is getting set to present three studies on Belsomra (suvorexant) at Sleep 2015, a conference starting this weekend in Seattle that's sponsored by the American Academy of Sleep Medicine and the Sleep Research Society. Consider the turmoil that has rocked the insomnia market over the last decade: First there was the series of bizarre reports from patients taking
Eventually Ambien and another top-seller, Lunesta (eszopiclone) from Sunovion Pharmaceuticals—which together once brought in more than $3 billion in annual sales—fell prey to generic competition.
But Merck’s Belsomra team faced enormous challenges out of the gate. Not only had the market for prescription sleep drugs cooled, but after an initial rejection from the FDA, Merck won approval for Belsomra only at low doses of 5 to 20 milligrams—rather than the 30 to 40 milligrams that had proven most effective in clinical trials. The agency, not surprisingly, was concerned about side effects at the higher doses.
Merck’s launch strategy focused on overcoming one major hurdle the company’s executives knew they had to overcome, says Eric Luthi, executive director and global brand leader for Belsomra. “As we started to plan how we were going to talk to patients about this product, we learned from our research that many [insomniacs] out there are dissatisfied with whatever they’re doing now, whether it’s nothing or treating with a prescription therapy,” Luthi says. “There are a lot of people looking for new options, but despite that, they are very skeptical about anything new. They get frustrated and jaded.”
Belsomra, in fact, is new. Unlike other insomnia drugs, which act on brain pathways that put people to sleep, Belsomra is a first-in-class product that works by blocking orexins—brain chemicals that keep people awake.
In an effort to get that difference across to consumers, Merck launched a multifaceted educational campaign, complete with unbranded television ads, branded print ads, a website (whyamisoawake.com) and even a mobile app called “Sleep Guru.” The campaign, which features cartoon characters, is largely aimed at teaching people what goes on in their brains when they’re wide awake in the middle of the night. The app walks users through exercises to help them adopt healthy sleep habits, like limiting their caffeine consumption and sticking to the same sleeping and waking schedule.
But educating physicians is also a priority, which is where events like this weekend’s Sleep conference come into play. During the meeting, Merck will be releasing additional data from the late-stage trials of Belsomra, including one study comparing responses of men and women. The FDA did not require Merck to recommend different doses for men and women, Luthi says, but the company did collect data looking at gender responses.
The analysis, which included 1,264 women and 707 men, found that the most common adverse effect reported by both groups was next-day drowsiness. There was a slight gender difference, though: At the two highest of the FDA-approved doses, 8.5% of women taking the drug reported drowsiness, vs. 3% of those taking a placebo. In men 3.4% of Belsomra users reported the side effect, compared to 3.6% of those on placebo. In all cases, the drowsiness was “transient and mild-to-moderate in intensity,” the study says.
As challenging as it will be to get the physician community on board with Belsomra, convincing insurers to pay for the product could be even tougher, especially considering the availability of cheap, generic Ambien. Still, says Luthi, he’s encouraged by the response, so far. Merck has already received positive coverage decisions for 50 million covered lives, and half of those patients were not required to try a less expensive drug before moving to Belsomra—a common tactic insurance companies use to lower costs. “We thinks this speaks to the value that even payers are seeing for having another option to help treat patients,” Luthi says.
Merck is planning to increase its outreach to consumers, a strategy that includes expanding the branded Belsomra print campaign this month, Luthi adds. He’s optimistic consumers will be open to the company’s message. After all, he says about one-third of the patients who have requested Belsomra so far are “continuous treaters”—people who are so troubled by their insomnia they reach for a sleeping pill almost every night.
“You would think that someone who chooses to treat every night is pretty happy with their therapy, but when we actually talk to those patients, what we find out is they’re not that happy,” Luthi says. “Frankly, that’s a market opportunity.”