BURLINGTON, Mass., April 2, 2014 /PRNewswire/ -- Decision Resources Group finds that surveyed U.S. and European psychiatrists ascribe the highest level of unmet need in insomnia treatment to be for new therapies with a reduced risk of abuse and tolerance. Several currently available insomnia therapies are designated as controlled substances owing to their potential for abuse, and interviewed thought leaders acknowledge abuse potential as a factor they consider when making prescribing decisions for insomnia. Although other available insomnia drugs are not controlled substances, surveyed psychiatrists identify reduced risk of abuse and tolerance as an area of differentiation for a novel therapy. However, given that the insomnia market is highly genericized, an emerging therapy will have to offer significant improvements on safety and efficacy, not only on abuse potential, to penetrate the market.
Other key findings from the DecisionBase report entitled Insomnia: In the Highly Genericized Insomnia Market, What Opportunities Remain for New Therapies?:
- Lunesta and Suvorexant: Based on clinical data and the opinions of interviewed thought leaders, suvorexant (Merck & Co.'s MK-4305) has clinical advantages over Lunesta (Dainippon Sumitomo/Sunovion Pharmaceuticals/Eisai) in terms of safety and tolerability, specifically a lower incidence of psychomotor events and residual next-day effects at the doses deemed approvable.
- Unmet need: In addition to the need for a therapy bearing a reduced risk of abuse and tolerance, surveyed psychiatrists identify significant unmet need for therapies associated with reduced residual next-day side effects, such as residual sedation. This finding is consistent with insight from interviewed sleep experts, who call for a novel insomnia medication with a more favorable pharmacokinetic profile, in turn reducing the frequency of next-day side effects.
- Formulary inclusion: Surveyed U.S. managed care organization pharmacy directors are receptive to reimbursing a novel insomnia therapy offering improvements in time awake after sleep onset and in the number of patients reporting next-day sleepiness, but they would require one hundred percent or more improvement in these metrics over that attained by current therapies. Therapies offering such robust benefits could nevertheless command a premium price in this market but payers would control costs by requiring step therapy and prior authorization.
Comments from Decision Resources Group Analyst Tamara Blutstein, Ph.D.:
- "The potential for a patient to develop abuse and tolerance with insomnia medications is a concern among interviewed psychiatrists, who take this risk into consideration when prescribing an insomnia therapy. Reduced risk for tolerance or dependence is an area where surveyed payers express a high willingness to grant favorable formulary status for a new insomnia therapy and where surveyed physicians identify unmet need in insomnia treatment."
- "The longer the half-life of a drug, the more effective it is at addressing sleep maintenance insomnia, unfortunately, the more likely it is to harbor residual next-day side effects. Interviewed psychiatrists note that no available insomnia therapies offer patients the ideal balance of a full night sleep without next-day impairment."
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