First approval for Yamanouchi's OCAS tech
approval - in the Netherlands - for a product based on its
proprietary OCAS drug delivery technology.
OCAS (Oral Controlled Absorption System) has been applied to a new formulation of the company's alpha blocker drug tamsulosin, used for the treatment of benign prostatic hyperplasia, which improves absorption from the gut and reduces the effects of taking medications alongside meals, which can reduce their take-up by the body.
Yamanouchi chief executive Toichi Takenaka said that the approval in the Netherlands for Omnic-OCAS (tamsulosin) was the first time that the drug delivery technology had made it through to the market.
OCAS technology enables a drug to be absorbed not only from the upper gastrointestinal (GI) tract (including the stomach and duodenum) but also in the lower GI tract (colon), from which drug absorption is usually difficult. It makes drugs less liable to the effects of meals than conventional capsule formulations, which should lead to a more favourable efficacy/safety profile, according to Yamanouchi. Omnic-OCAS is available as a once-daily controlled-release tablet.
Yamanouchi markets tamsulosin under the brand name Omnic in Europe and Harnal in Japan. A marketing authorization application (MAA) was submitted in the EU in January via the mutual recognition procedure (MRP) with the Netherlands as the rapporteur.
Tamsulosin was first launched in 1993 in Japan and is now in the market in 65 countries with worldwide sales of over Y190 billion in 2003.
Fast-dissolving form
Meanwhile, Yamanouchi also said that it has obtained approval for a new fast-melt formulation of the drug, called Harnal D, in Japan.
Harnal D was developed using Yamanouchi's proprietary drug delivery technology WOWTAB (without water tablet). This is intended for use by the elderly or those with impaired swallowing function, as it can be ingested without water since it quickly disintegrates upon contact with saliva in the mouth.
