Navigation Links
ABSTRAL® (fentanyl) Sublingual Tablets CII, First-in-class, Sublingual, Immediate Release Opioid for Managing Breakthrough Cancer Pain, Now Available in the U.S.
Date:4/4/2011

e analgesic that disintegrates quickly under the tongue. It offers an alternative therapeutic choice to patients and clinicians with a simple, patient-friendly and predictable way of delivering fentanyl transmucosally, while retaining the individualized dose titration aspects required for optimal treatment of breakthrough pain.

ABSTRAL REMS Program

ABSTRAL is the first and only sublingual, transmucosal, immediate release fentanyl product to be available through a class-wide Risk Evaluation and Mitigation Strategy (REMS) program mandated and approved by the F.D.A., which requires health care professionals and pharmacies that prescribe or distribute ABSTRAL to patients in the community setting to enroll in the program. Starting in April, ABSTRAL will be available in those chain and independent pharmacies that have enrolled in the ABSTRAL REMS program.

"The improper use of opioid medications is a serious issue with potentially devastating consequences for patients and the broader community. Through the ABSTRAL REMS program, ProStrakan has committed to providing necessary education around the benefits and risks of opioid pain management," said Abid Karim, President of Global Commercial Operations. "ProStrakan strives to provide access to safe and effective treatment options to address the unmet needs of cancer patients and the healthcare community."

The goal of the ABSTRAL REMS program is to provide effective access to ABSTRAL while mitigating the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by:

  • Prescribing and dispensing ABSTRAL only to appropriate patients, which includes use only in opioid-tolerant patients.
  • Preventing inappropriate conversion between fentanyl products.
  • Preventing accidental exposure to children and others for whom it was not prescribed.
  • Educating prescribers, pharmacists, and patients on the potentia
    '/>"/>

SOURCE ProStrakan Group plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. MonoSol Rx, LLC Announces Suboxone Sublingual Film Achieves 25% Share of Total U.S. Suboxone Market Volume at Year-End 2010
2. INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray
3. Investigational Sublingual Allergy Immunotherapy Tablet Meets Primary Endpoint in a Study of Adult Subjects With a History of Grass Pollen Allergies
4. AcelRx Pharmaceuticals Reports Positive Results from a Clinical Trial of Sublingual Sufentanil/Triazolam NanoTab(TM) Combination (ARX-03) in Treating Procedural Pain and Anxiety
5. Qualitest Receives FDA Approval for Toresmide Tablets (Generic Demadex®) 5 mg, 10 mg, 20 mg, 100 mg, for the Treatment of Edema Associated with Congestive Heart Failure, Renal Disease, or Hepatic Disease
6. Actavis Receives Approval of Valacyclovir Hydrochloride Tablets in the U.S.
7. Florida Pain Clinic Society: 3.7 Billion Oxycodone Tablets Dispensed in U.S.
8. FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents
9. Mylan Launches First Generic Version of Vfend® Tablets
10. Actavis Receives Approval of Pantoprazole Sodium Delayed-Release Tablets, USP in the U.S.
11. Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg / 500 mg, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E and T023M10A and Phenobarbital Tablets, USP 32.4 mg, ND
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... CITY, Calif. , Oct. 22, 2014 /PRNewswire/ ... today announced that results from the  IAP310 study ... Pain Medicine (RAPM), a peer-reviewed journal with ... Phase 3 trial evaluating the safety and efficacy ... sublingual tablet system (SSTS), for the treatment of ...
(Date:10/22/2014)... Oct. 22, 2014  Regulus Therapeutics Inc. ... company leading the discovery and development of ... it has demonstrated human proof-of-concept with a ... evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting ... C virus infection ("HCV").  Interim results from ...
(Date:10/20/2014)... , Oct. 20, 2014  PneumRx, Inc. ( ... pulmonology, today announced completion of enrollment in their RENEW ... Clinical Study is the FDA-approved IDE pivotal trial for ... emphysema. It was anticipated that the study, ... 2013, would take until the end of 2014 to ...
Breaking Medicine Technology:AcelRx Announces Publication of Zalviso Phase 3 Abdominal Trial Results 2A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 2A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 3A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 4A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 5A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 6A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 7A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 8PneumRx Completes RENEW Pivotal Trial Enrollment 2PneumRx Completes RENEW Pivotal Trial Enrollment 3
(Date:10/22/2014)... Healthcare professionals who are looking for ... home or on-the-go via laptops, tablets or mobile ... premium Seminar-on-Demand CE courses. The new courses add ... hours of CE course offerings, allowing therapy ... such a diverse library, there’s something for everyone. ...
(Date:10/22/2014)... 22, 2014 Although there are only 24 hours ... many people who have trouble finding time within their busy schedules ... for long periods of time to get in shape. Here are ... on the go. , Change Up Your Commute , Consider ... to add some exercise into your daily routine. If you must ...
(Date:10/22/2014)... 22, 2014 Richard Carlson, Managing Partner ... leader with over 25 years experience. Mr. Carlson ... the areas related to EDI, B2B Commerce, RFID and ... Editorial Advisory Board member for Pharmaceutical Commerce Magazine and ... Fin Group is a management and technology consulting firm ...
(Date:10/22/2014)... Reinberg HealthDay Reporter , TUESDAY, ... weight and length may be showing a genetic propensity for ... certain genes have been linked to increased body fat, but ... and lean muscle, the researchers said. At 1 year, ... ages 2 and 3, however, these genes were linked to ...
(Date:10/22/2014)... 2014 (HealthDay News) -- Two sisters in high school ... Ilina and Medha Krishen use electronic stethoscopes, which ... trouble in breathing patterns or heartbeats. Ilina, a ... wanted to find a way to detect early lung ... an electronic stethoscope, Ilina recorded one breath cycle each ...
Breaking Medicine News(10 mins):Health News:Top Provider of Continuing Education at Home Releases 20 New Online Courses 2Health News:HealthGuideMD Presents Ways to Improve Your Exercise and Fitness 2Health News:Rich Carlson and Marc Duey to Hold Workshop at CBI’s Specialty Pharmacy and Distribution Networks Conference 2Health News:Tall, Heavy 1-Year-Olds May Be at Risk for Obesity Later, Study Finds 2Health News:Teen Sisters Develop Ways to Measure Lung, Heart Damage 2
... Feb. 10 SilverCensus.com Inc. ( http://www.silvercensus.com ), ... healthcare professionals, announced today its expansion to a ... a Foundation that aims to revolutionize the way ... are a comprehensive senior living and senior healthcare ...
... Myeloma and Bone Cancer Research (IMBCR) have uncovered a ... within tumors.LOS ANGELES, Feb. 10 IMBCR researchers uncovered ... their own blood supply. Recent studies have shown that ... now show that PTN produced by tumor cells in ...
... AVC-Intra encoding, 64-bit support, seamless integration and improved quality ... MainConcept GmbH, a wholly-owned subsidiary of DivX, Inc. ... world,s leading providers of video/audio codecs and software development ... today announced the release of Codec SDK 8.0 with ...
... Technique Breast-Specific Gamma Imaging (BSGI) Resulting in Record ... Technologies, Inc., a leader in molecular breast imaging, ... the strongest fourth quarter in the company,s history. ... sales from 2007 to 2008 as molecular breast ...
... Feb. 10 Arete Therapeutics Inc. today,announced the initiation ... orally-,administered soluble epoxide hydrolase (s-EH) inhibitor being developed for,the ... involved in the metabolism,of arachidonic acid, a key signaling ... "Our AR9281 Phase II clinical trial ...
... Feb. 10 - Zeus, Inc. announces new product name changes that ... unaltered in composition and processing. They remain the same quality products ... , New brand names are as follows: , ... New trademarked product Aeos (TM), formerly known as ...
Cached Medicine News:Health News:SilverCensus.com Launches National Website for Caregivers, Senior Citizens, Healthcare Professionals 2Health News:Researchers Identify Novel Mechanism That Make Cancer Tumors Grow 2Health News:MainConcept Releases New Codec SDK 8.0 2Health News:MainConcept Releases New Codec SDK 8.0 3Health News:MainConcept Releases New Codec SDK 8.0 4Health News:Dilon Technologies Leads Molecular Breast Imaging Expansion 2Health News:Arete Therapeutics Initiates Phase IIa Clinical Trial for AR9281, a Novel s-EH Inhibitor to Treat Type 2 Diabetes 2Health News:Arete Therapeutics Initiates Phase IIa Clinical Trial for AR9281, a Novel s-EH Inhibitor to Treat Type 2 Diabetes 3Health News:Zeus Announces Product Name Changes 2
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: