Launch of Oral Once-Daily Tramadol Sustained Release Tablet
Nippon Shinyaku Co., Ltd. and Pfizer Japan Inc. (Headquarters: Tokyo, Japan; President: Ichiro Umeda; “Pfizer”) announced that two companies have launched an oral tramadol sustained release tablet “Onetram? tablet 100 mg”, for which Nippon Shinyaku obtained manufacturing and marketing authorization in March 2015.
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 (Headquarters: Dublin, Ireland). The tablet is a once-daily oral formulation which 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.
While all oral formulations of tramadol approved so far in Japan have been immediate releasing medicines, Onetram? is the first controlled release tablet. Compared with the immediate releasing tablets which required several administrations per day, the new formulation should increase medication adherence of patients by providing a stable analgesic effect with a once-daily oral administration. 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 and Pfizer expect 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 will provide sales promotion exclusively in Japan, as with “Tramal? Capsule 25 mg, 50 mg and Tramal? OD tablet 25 mg, 50 mg”.