Analysis: New Drug to Wake Up Sleep Market

By STEVE MITCHELL

Despite the recent problems that have hit the insomnia treatment field, the market is set to grow by $1.6 billion over the next 10 years, led by Sanofi aventis’ first-in-class medication, eplivanserin, according to a new report released Thursday.

What will drive the growth of the insomnia market is the continued uptake of Sanofi aventis’ Ambien CR, which has experienced a strong uptake in the U.S., Charlotte Mackey, an analyst with Decision Resources and author of the report, told United Press International.

Also, I believe that the launch of a new class called the serotonin antagonists, will be a key driver of growth in the insomnia market as there are several of these in late stage development and they have the potential to satisfy some important unmet needs and the market will be receptive to a drug with a novel mechanism of action, Mackey added.

Datamonitor projects the insomnia market, which is currently worth $6.1 billion, will grow to $7.7 billion by 2016, with more than half of the increase coming from Sanofi’s serotonin antagonist eplivanserin.

The current market is dominated by GABAa receptor modulators, but Merck and Lundbeck’s decision to discontinue development of their candidate, gaboxadol, due to disappointing phase 3 results, may open the door for the serotonin antagonists.

This bodes well for Sanofi, which has two serotonin antagonists in development, including eplivanserin.

I think that the continued uptake of Ambien CR, and the successful launch of its current pipeline insomnia drugs will mean that Sanofi aventis stands a good chance of remaining the leading company in the insomnia market, Mackey said. It’s already established relationships with physicians through the success of Ambien will be really important to the success of its next insomnia drug.

Eplivanserin, which Datamonitor estimates will generate $913 million in sales by 2016, is expected to be the first serotonin antagonist to the market, which will give it a marketing advantage initially.

However, eplivanserin could soon face a crowd of competitors. There are eight serotonin antagonists and agonists in the pipeline. Mackey forecasts Organon’s Org-50081 will be second to market, but beyond that, it’s difficult to predict because many of them are still early in development.

One important advantage of the serotonin antagonists is that they effectively promote sleep but do not appear to cause next-day drowsiness.

In addition, this class is unlikely to be designated as a controlled substance by the Drug Enforcement Agency.

I think this will have a positive influence on physicians’ and patients’ perceptions of the drug’s safety, and it also means that patients will be able to use it over a longer period of time, Mackey said.

Although the current insomnia treatments were hit with a warning from the Food and Drug Administration in March about the potential for allergic reactions and other problems, such as sleep-driving, these products will probably continue to do well.

I’m not convinced that the FDA’s warnings of these problems will have a negative effect on the sales of insomnia drugs, Mackey said. At least from the key opinion leaders I have interviewed, it seems that these warnings are unlikely to affect the prescribing decisions of physicians.

Michael Sateia, a member of the American Academy of Sleep Medicine’s board of directors and director of the sleep disorders center at Dartmouth University, told UPI it’s too early to say whether the FDA’s warnings are impacting prescribing practices of physicians.

It does raise concerns, Sateia said. But he added that many of the adverse effects could be minimized with better education of both patients and physicians.

The issue also provides an opportunity for increasing the awareness among physicians there are other strategies for treating insomnia that don’t involve medications.

Medications still have an important role to play and can be safe and effective for many patients, but having said that, it’s important to educate physicians that there are many, many effective behavioral therapies that may obviate the need for as much medication as is currently used, Sateia said.

One such strategy is cognitive behavioral therapy, which can help lower the dosage or the discontinuation of sleeping pills, he said.

There’s a growing emphasis on this as opposed to purely pharmacological solutions, Sateia said.

One barrier to getting these strategies in treating insomnia is insufficient resources. In addition, both patients and healthcare providers are often not aware this is a treatment option. So the American Academy of Sleep Medicine is working to promote increased awareness among physicians about using these behavior therapies, he said.