MONHEIM, Germany (AFX) - Schwarz Pharma AG said that phase III data on its Lacosamide drug showed clinically relevant and statistically significant reduction in diabetic neuropathic pain, paving the way for filing for approval with European an US regulatory authorities.
The drug, which has a peak sales potential of 600 mln eur for this indication, was compared to placebo, and the company said the safety profile of Lacosamide is comparable to previous trials, with the most common adverse events being dizziness, nausea and headache.
Neuropathic pain is caused by a functional disorder of the central or peripheral nervous system. Diabetic neuropathic pain is a very common chronic pain, under which some 11 mln diabetics suffer.
Earlier this week, data from another phase III trial on the drug, this time to treat epilepsy, also showed that the drug helped reducing seizure frequency, and again it was well tolerated in epileptic patients.
For epilepsy the drug has an annual peak sales potential of 300 mln eur.
"Source":[ http://www.forbes.com/business/feeds/afx/2006/03/31/afx2636131.html].