The pharmaceutical unit of L'Oreal, Synthelabo SA, suffered an unexpected plunge in its share price last week on news that the company is temporarily suspending development of its new non-benzodiazepine anxiolytic product, Ananxyl (alpidem), in the USA. The product is already marketed in France.
Synthelabo said that its joint venture with G D Searle, Lorex Pharmaceuticals, had halted further development of the drug in the USA because of "divergent results" in clinical trials intended for inclusion in its New Drug Application to the Food and Drug Administration. Synthelabo says it plans to carry out complementary studies to discover the reason for the divergent findings before making a final decision on whether to continue with filing for US approval.
The company also said that the complementary studies may delay licensing applications in other European countries.
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