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March 15, 2012 8:39 pm

Lundbeck’s alcoholism drug faces EU regulatory challenges

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This article is provided to readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market.


Lundbeck (CPH:LUN) and Biotie’s (HEL:BTH1V) drug for alcoholism will be scrutinized by the European drug regulatory authority as it failed to pass one bar of efficacy in a clinical trial, according to experts interviewed by BioPharm Insight.

However, approval is not impossible given the need for such therapy and the overall body of evidence supporting the drug, they said.

Nalmefene or Selincro blocks a common receptor in the brain-the opioid-receptor- in order to reduce the amount of alcohol intake in alcohol-dependent patients and is taken as needed by the patient.

In the pivotal Phase III program, which included efficacy trials titled ESENSE 1 and ESENSE 2 and a safety trial, SENSE, results were mixed.

Drug reduces total alcohol consumption and heavy drinking days

Data are not mixed but robust and consistently show the efficacy of nalmefene in reducing both total alcohol consumption (TAC) and heavy drinking days (HDD), a Lundbeck spokesperson said. “The regulatory process is ongoing and we cannot comment on it at this time,” the spokesperson added.

At the European Psychiatry Conference in Prague, it was announced that ESENSE 1 met the efficacy hurdles or co-primary endpoints on a monthly basis, which were a significant reduction in HDD and TAC, when the drug was given for six months.

Yet, ESENSE 2 showed more varied results and did not meet all endpoints on all months. At the six-month data point it significantly reduced HDD but not TAC. Mixed results were also reported on the secondary endpoint for the clinical global impression scale (CGI), a common scale to measure symptoms, in both ESENSE 1 and ESENSE 2. However, clinicians were expecting mixed results, as previously reported by this news service.

The Phase III data is likely to impact the chances of approval because technically the primary endpoint of the ESENSE 2 trial was not met, Professor Karl Mann, chair of addiction medicine at the Scientific Departments of Central Institute of Mental Health in Germany, said. Still, it is not unusual for only two out of three trials to be positive with an active drug in alcohol dependence, he added.

Results are very promising, but efficacy was modest, Professor Alho Hannu, who was at the EPA conference from the University of Helsinki, said. He added previous studies with naltrexone and long-term studies demonstrated that nalmefene is safe.

“We are pleased with the data and optimistic regarding approval,” the Lundbeck spokesperson said.

Mann said there is no doubt that there is a positive signal with nalmefene, noting the difference from placebo was significant at the five-month point but not at the six-month point.

New approach for treating alcoholism, a costly addiction

The European Medicines Agency (EMA) is struggling with new concepts emerging in psychopharmacology such as alcohol reduction over abstinence, Professor David Nutt, Edmond J Safra chair of Neuropsychopharmacology at Imperial College London, said. However, there have been efforts to introduce the concept of a “drinking regulator” drug, Nutt said, adding that he hoped the EMA could see past the inconsistencies in the data of the second trial because the effects are largely clinically meaningful.

Conceptually, the proposed use is a “revolution” as this could be the first approved treatment which could prevent binge drinking by reducing the number of drinks within one session, Nutt said. A reduction in HDD will have a huge health benefit in patients with alcohol dependence, including an impact on personal health and secondary consequences, he added.

Nalmefene presents a totally new paradigm of treating alcohol dependence, as all treatments to date have attempted to promote abstinence with very poor results, Professor Philip Gorwood, assistant to the department head at the Clinique des Maladies Mentales et de l’Encéphale at Centre Hospitalier Sainte Anne in Paris, France, agreed.

He said that it was yet to be seen whether the trial data would overcome the rules of the EMA. However, typically the average benefit from drugs in this field is small, Gorwood noted.

A big part of the EMA evaluation will be the timing of treatment, because the trials only looked at the treatment for six months to one year, but patients could be on the treatment for more than five years, Gorwood said.

Antidepressants are often approved with a label of 12 weeks, although in real life prescriptions are for a longer period of time, Biotie’s Chief Executive Officer Timo Veromaa said, adding that this would likely be the very topic that Lundbeck would be discussing with the regulators.

Veromaa said he would be “shocked” if the drug was not approved, adding that a third Phase III trial, published in 2007, demonstrated a significant reduction on both the TAC and HDD endpoints. He noted that the trial was run in 400 patients in Finland.

Gorwood noted that cost will be a major influencing factor, adding that it was recently found in a review that alcohol consumption was the number three burden in France. Nutt pointed to a recent study, which found that alcohol consumption was the most predictive factor for morbidity in men and costs the European healthcare system around EUR 108bn a year.


For more information or to inquire about a trial please email or call Americas: +1 212-500-1384 or Europe: 44 (0)20 7059 6202

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