The second bioequivalence study is completed

csm_067A8395-small_52c7cbfe3c

The result is positive and means that all studies required for pharmaceutical registration are completed.

Enorama Pharma has completed the second bioequivalence study of its nicotine gum with fruit flavour. The result is positive and means that all studies required for pharmaceutical registration are completed.

Enorama Pharma has received the result from the revised bioequivalence study in which Enorama Pharma’s 4 mg nicotine gum fruit was compared with the reference product Nicorette 4 mg. The result is positive which means that Enorama Pharma’s product is bioequivalent with Nicorette.

Enorama Pharma has now successfully completed bioequivalence studies of the 4 mg nicotine gum with mint and fruit flavour as well as 3- and 6-months accelerated stability studies. These results combined, confirm that Enorama Pharma’s product, manufactured with compressed gum technology, is ready for pharmaceutical registration in relevant markets.