Approval of Once-Daily Tramadol Sustained Release Tablet
Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan; President: Shigenobu Maekawa) announced that it has received manufacturing and marketing authorization for a once-daily tramadol sustained release tablet “Onetram? tablet 100 mg” (Development Code: NS-24), which is licensed in from Endo Ventures Limited (successor to Labopharm Europe Limited).
Onetram? is a tablet of tramadol hydrochloride, which is the same active ingredient as in “Tramal? Capsule 25 mg, 50 mg and Tramal? OD tablet 25 mg, 50 mg (four times administration per day)” launched by Nippon Shinyaku for the treatment of cancer pain and chronic pain, but applied to a unique sustained release technology owned by Endo Ventures Limited. The tablet is a once-daily oral formulation, and has both fast-acting and long-lasting properties by consisting of an immediate releasing outer layer and a 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, while Onetram? is the first controlled release tablet.
The new formulation is highly useful and should increase medication adherence of patients because it provides a stable analgesic effect with a once-daily oral dose. That is a large benefit for patients, who require pain control on a long term basis.
By adding Onetram? to their tramadol line-up, Nippon Shinyaku expects to increase the number of choices of medicine and to contribute to the improvement of quality of life in patients suffering from pain.
Nippon Shinyaku will market and distribute the product, while Pfizer Japan will provide sales promotion exclusively in Japan, as with “Tramal? Capsule 25 mg, 50 mg and Tramal? OD tablet 25 mg, 50 mg”.