| March 18, 2010 |
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The study was a cross-over, PK study, with 12 healthy volunteers that received the AP-Baclofen and the Baclofen currently on the market (Lioresal®). Blood plasma levels of Baclofen were measured at frequent intervals up to 26 hours after administration. The absorption phase of Baclofen was prolonged, by using the Accordion, to 11 hours, in comparison to the 2.5 hours provided by the marketed Lioresal®. The range of Baclofen plasma levels, obtained with the AP- -Baclofen were similar to the range which is currently obtained with TID administration of Lioresal®. The overall PK profile, achieved with the AP-Baclofen, was significantly flatter. Baclofen is currently approved for the treatment of spasticity. There are approximately 925K patients in the US who suffer from diseases that are associated with spasticity, including Multiple Sclerosis, Cerebral Palsy, Parkinson's disease, Stroke, Traumatic Brain Injuries, SCI, and Restless Leg Syndrome (RLS). Baclofen is currently administered 3-4 times a-day, and is associated with various side effects (including drowsiness, weakness and fatigue) that are probably related to the drug's plasma profile. |