Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

Abstral® Receives Japan’s MHLW Approval

Published: Tuesday, September 24, 2013
Last Updated: Tuesday, September 24, 2013
Bookmark and Share
Approval to manufacture highly potent compound for breakthrough pain relief in cancer treatment granted.

Recipharm Stockholm has announced that the company was informed on September 20, 2013 by the R&D-based pharmaceutical company, Kyowa Hakko Kirin Co. Ltd. (Tokyo, Japan, President and CEO: Nobuo Hanai, “Kyowa Hakko Kirin”) that Abstral® sublingual tablet (nonproprietary name: fentanyl citrate; referred to below as “Abstral®”), has been approved for manufacturing and marketing by Japan's Ministry of Health, Labour and Welfare(MHLW).

The approval allows Recipharm to carry out commercial scale manufacturing and packaging of Abstral® for supply to the Japanese market through Kyowa Hakko Kirin.

The drug product, Abstral® is a novel, highly potent, rapid disintegration, sublingual (under the tongue) formulation of fentanyl citrate.

This well-established opioid is used extensively for fast relief and management of episodes of breakthrough pain experienced by cancer patients that are already in receipt of opioid analgesics for cancer pain.

Japanese regulatory agency assessed Recipharm’s suitability through detailed analysis of the company’s history, capabilities, proven track record and the reliability of the supply chain set to take the product through to Japan, together with a thorough review of all clinical data and product documentation.

Recipharm will compress and formulate Abstral® in tablet dosage at its manufacturing site in Årsta, with all packaging performed at the company’s Jordbro complex. Quality control will be initiated in laboratories located in central Stockholm.

Thomas Beck, Director of Quality and Qualified Person at Recipharm Stockholm commented: “We are delighted to receive Japan’s MHLW approval to carry out a combination of both the manufacturing and the packaging of such a product, for onward supply to the Japanese market. Indeed, we are pleased, both because securing such authorization from a regulatory body outside of the EU is an extremely complicated process, especially in the case of Japan, and due to the fact that Abstral® is a highly innovative drug that enables fast relief of pain endured by patients undergoing cancer treatment.”

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Recipharm Appoints Prof. Hans Lennernäs to One of its Operating Boards
Prof. Lennernäs currently manages an IMI project entitled OrBiTo to improve oral drug delivery.
Tuesday, February 05, 2013
Scientific News
Revolutionary Technologies Developed to Improve Outcomes for Lung Cancer Patients
Breath test to detect lung cancer brings oxygen directly to the wound.
New Class of RNA Tumor Suppressors Identified
Two short, “housekeeping” RNA molecules block cancer growth by binding to an important cancer-associated protein called KRAS. More than a quarter of all human cancers are missing these RNAs.
Mathematical Model Forecasts the Path of Breast Cancer
Chances of survival depend on which organs breast cancer tumors colonize first.
Exploring the Causes of Cancer
Queen's research to understand the regulation of a cell surface protein involved in cancer.
Nanocarriers May Carry New Hope for Brain Cancer Therapy
Berkeley lab researchers develop nanoparticles that can carry therapeutics across the brain blood barrier.
RNA-Based Drugs Give More Control Over Gene Editing
CRISPR/Cas9 gene editing technique can be transiently activated and inactivated using RNA-based drugs, giving researchers more precise control in correcting and inactivating genes.
University of Glasgow Researchers Make An Impact in 60 Seconds
Early-career researchers were invited to submit an engaging, dynamic and compelling 60 second video illuminating an aspect of their research.
Metabolic Profiles Distinguish Early Stage Ovarian Cancer with Unprecedented Accuracy
Studying blood serum compounds of different molecular weights has led scientists to a set of biomarkers that may enable development of a highly accurate screening test for early-stage ovarian cancer.
Dead Bacteria to Kill Colorectal Cancer
Scientists from Nanyang Technological University (NTU Singapore) have successfully used dead bacteria to kill colorectal cancer cells.
CRISPR-Cas9 Gene Editing: Check Three Times, Cut Once
Two new studies from UC Berkeley should give scientists who use CRISPR-Cas9 for genome engineering greater confidence that they won’t inadvertently edit the wrong DNA.

SELECTBIO Market Reports
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos