H. Lundbeck A/S (OMX: LUN) announced results of the three large Phase 3 studies with Selincro (nalmefene) for the treatment of alcohol dependence in connection with its presentations at the 2012 European Congress of Psychiatry. The headline statistic shows that patients treated with the drug were able to reduce alcohol intake by 66% on average after six months of treatment.
The drug aims to change treatment paradigm of alcoholism from total abstinence to reduction in consumption empowering the patient to take the drug on as-needed basis when they feel the urge to start drinking. Lundbeck had previously said that not all clinical endpoints were statistically significant albeit they all showed a positive trend vs. placebo. This was what investors were focusing on in today’s results.
Heavy drinking days dipped over 60% in both placebo and Selincro over a 6 month period with a statistically significant improvement at 5% confidence level for Selincro group. It would certainly have been preferable to be able to use a tighter criteria, particularly when it comes to commercial potential of the drug. A further 50% reduction over the next six months was seen in the one longer-term study, which was mainly looking at safety and tolerability, where as placebo group did not show further improvement.
The null-hypothesis for superiority of the drug over placebo in lessening total alcohol consumption could not be rejected at 5% level in ESENSE 2. In ESENSE1 the p value was below 0.05 in that endpoint as well. Statistically significant improvement in secondary endpoint of liver enzymes over placebo group is positive sign toward approval. Biotie Therapies (OMXH: BTH1V), which stands to gain a milestone from approval and royalties from sales has gained 6% for the day. Lundbeck is down slightly.
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