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

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 2,400+ scientific posters on ePosters
  • More than 3,700+ 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 TechnologyNetworks.com 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
Long Telomeres Associated with Increased Lung Cancer Risk
Genetic predisposition for long telomeres predicts increased lung adenocarcinoma risk.
First Artificial Ribosome Designed
Researchers at the University of Illinois at Chicago and Northwestern University have engineered a tethered ribosome that works nearly as well as the authentic cellular component, or organelle, that produces all the proteins and enzymes within the cell.
Identifying a Key Growth Factor in Cell Proliferation
Researchers discover that aspartate is a limiter of cell proliferation.
A Gene-Sequence Swap Using CRISPR to Cure Haemophilia
For the first time chromosomal defects responsible for hemophilia have been corrected in patient-specific iPSCs using CRISPR-Cas9 nucleases
New Tool Uses 'Drug Spillover' to Match Cancer Patients with Treatments
Researchers have developed a new tool that improves the ability to match drugs to disease: the Kinase Addiction Ranker (KAR) predicts what genetics are truly driving the cancer in any population of cells and chooses the best "kinase inhibitor" to silence these dangerous genetic causes of disease.
New Material Opens Possibilities for Super-Long-Acting Pills
A pH-responsive polymer gel could create swallow able devices, including capsules for ultra-long drug delivery.
New Tool For Investigating RNA Gone Awry
A new technology – called “Sticky-flares” – developed by nanomedicine experts at Northwestern University offers the first real-time method to track and observe the dynamics of RNA distribution as it is transported inside living cells.
Access Denied: Leukemia Thwarted by Cutting Off Link to Environmental Support
A new study reveals a protein’s critical – and previously unknown -- role in the development and progression of acute myeloid leukemia (AML), a fast-growing and extremely difficult-to-treat blood cancer.
New Weapon in the Fight Against Blood Cancer
This strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
TOPLESS Plants Provide Clues to Human Molecular Interactions
Scientists at Van Andel Research Institute have revealed an important molecular mechanism in plants that has significant similarities to certain signaling mechanisms in humans, which are closely linked to early embryonic development and to diseases such as cancer.
SELECTBIO

Skyscraper Banner
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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!