New Drug Application of Once-Daily Tramadol Sustained Release Tablet
Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan; President: Shigenobu Maekawa) announced that it has submitted a New Drug Application for a once-daily tramadol sustained release tablet (Development Code: NS-24), which was licensed in from Paladin Labs Inc.
NS-24 is a tablet of tramadol hydrochloride, which is the same active ingredient as in “Tramal® Capsule 25 mg and 50 mg (four times administration per day)” launched by Nippon Shinyaku for the treatment of cancer pain and chronic pain, but contains Contramid® technology, a patented, controlled-release drug delivery system that provides novel release profiles for solid oral dosage. The tablet has both immediate and controlled release properties by consisting of an immediate releasing outer layer and sustained releasing core.
Tramadol hydrochloride is a centrally acting analgesic originally synthesized in Germany, and launched with various formulation forms in more than one hundred countries. As a non-scheduled medicine in Japan, tramadol is prescribed for the treatment of cancer pain and chronic pain for the many patients for whom non-opioid analgesics are not adequate. However, all oral formulations of tramadol approved in Japan have been immediate releasing medicines, and have needed to be taken several times per day.
The NDA is filed after confirmation in clinical studies in Japan of the efficacy and safety of the product with once daily administration to patients suffering from cancer pain and chronic pain. The new formulation will increase medication adherence of patients. By adding NS-24 to their tramadol line-up, Nippon Shinyaku expects to contribute to the improvement of QOL in patients suffering from pain.
Upon receiving approval, Nippon Shinyaku will market and distribute the product, while Pfizer Japan will conduct its sales promotion exclusively in Japan, as with “Tramal® Capsule 25 mg and 50 mg”.