Oral Facial Pain

December 10, 2007

Targacept issued negative results from a phase II trial of TC-2696 for the treatment of acute post-operative pain. This US based, randomized, double-blind, single-dose trial enrolled one hundred and eighty one subjects. The subjects received 10, 25 or 50 mg TC-2696, ibuprofen (400 mg) or placebo following third molar extraction surgery. Treatment was well tolerated with an adverse event profile similar between all arms. However, TC-2696 did not meet the primary endpoints, superior pain relief four or six hours after dosing as compared to placebo. Targacept plans to fully evaluate the data in order to determine a future course of action for TC-2696.

September 16, 2002

Intranasal Ketamine demonstrated positive phase I/II results in the treatment of moderate to severe pain following oral surgery. Three self-administered doses (10 mg, 30 mg, or 50 mg) of Intranasal Ketamine were received by 40 subjects, who had undergone the removal of two to four molars. Results indicated that in comparison to placebo, Intranasal Ketamine had a significantly faster onset of pain relief with dose-related efficacy and duration of effect. Dose-dependent onset of pain relief occurred within two to 10 minutes following intranasal administration and total pain relief scores were statistically significant for the 50 mg dose. Similar trends were also observed in the 10 mg and 30 mg doses. Intranasal Ketamine is being developed by Innovative Drug Delivery Systems.