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ProStrakan Group's ABSTRAL(R) (fentanyl) Sublingual Tablets CII, First-in-class, Sublingual, Immediate Release Opioid for Managing Breakthrough Cancer Pain, Now Available in the U.S.


4/4/2011 7:05:34 AM

BEDMINSTER, N.J., April 4, 2011 /PRNewswire/ -- ProStrakan Group plc (LSE: PSK) today announced the availability of ABSTRAL® (fentanyl) sublingual tablets as the first rapidly-disintegrating tablet placed under the tongue for breakthrough cancer pain. The U.S. Food and Drug Administration (F.D.A.) approved ABSTRAL, an opioid analgesic, in January 2011 specifically for the management of breakthrough pain in cancer patients, 18 years of age or older, who are already receiving, and who are tolerant to, opioid therapy for their underlying persistent cancer pain. ABSTRAL is available only through an F.D.A mandated program, ABSTRAL REMS (Risk Evaluation and Mitigation Strategy).

Breakthrough cancer pain, common in one-half to two-thirds of people with cancer-related pain, affects a patient's quality of life including physical and emotional health, interpersonal relationships and ability to engage in certain activities. Breakthrough pain (BTP) is described as severe pain that "breaks through" regular pain medicine.(1) Opioids are among the most potent and effective analgesics, or medicines given to reduce pain, but unfortunately are also some of the most misused and abused medicines.

"Breakthrough pain in cancer patients is very serious and debilitating. As we aim to manage our patients' level of pain, there are often barriers that limit the effectiveness of opioid treatments, including route of administration and poor access to currently available treatments," said Srinivas Nalamachu, M.D., ABSTRAL Principal Investigator, International Clinical Research Institute, Inc., and Kansas City University of Medicine and Biosciences. "With ABSTRAL and the ABSTRAL REMS program, we have the ability to offer patients a proven opioid pain management therapy that is fast acting and easy to use, while also minimizing risks for abuse, addiction, overdose or diversion through a stringent F.D.A.-Approved REMS."

ABSTRAL is the only available 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 potential for misuse, abuse, addiction, and overdose.

For more information on ABSTRAL and the ABSTRAL REMS program, please visit www.ABSTRAL.com and www.ABSTRALREMS.com or call 1-888-ABSTRAL (1-888-227-8725).

ABSTRAL Clinical Data

A double-blind, placebo-controlled, crossover study evaluated the clinical efficacy of ABSTRAL versus placebo in the treatment of opioid tolerant, adult cancer patients with BTP.

Open-label titration identified a dose of ABSTRAL in which a patient obtained adequate pain relief with tolerable side effects, within the range of 100 mcg to 800 mcg. In the double-blind efficacy study, patients who identified a successful dose were randomized to a sequence of 10 treatments; seven with ABSTRAL and three with placebo.

Of the 131 patients who entered the titration phase of the study, 78 (60 percent) achieved a successful dose during the titration phase. Sixty-six patients entered the double-blind phase and 60 completed the study. The dose of ABSTRAL was determined by titration starting at 100 mcg. The final titrated dose of ABSTRAL for breakthrough cancer pain was not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain. In a second open-label safety study using an identical titration regimen, 96 of 139 patients (69 percent) who entered the study titrated to a dose in which the patient obtained adequate pain relief with tolerable side effects during the titration phase.

Common adverse reactions associated with ABSTRAL include nausea, constipation, drowsiness and headache.

About ABSTRAL®

ABSTRAL® (fentanyl) sublingual tablets, a rapidly disintegrating sublingual tablet formulation of fentanyl citrate designed for oral transmucosal delivery, is approved in the U.S. for the management of breakthrough pain in cancer patients, 18 years of age or older, who are already receiving, and who are tolerant to, opioid therapy for their underlying persistent cancer pain. ABSTRAL is available in strengths of 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg.

ABSTRAL is in-licensed by ProStrakan for Europe, the U.S., Canada, and Mexico from Sweden-based Orexo AB.

Important ABSTRAL® Safety Information

Do not use ABSTRAL unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant).

Keep ABSTRAL in a safe place away from children. ABSTRAL can cause an overdose and death in any child who takes it. Get emergency help right away if a child takes ABSTRAL. If possible, try to remove ABSTRAL from the mouth.

ABSTRAL can cause life-threatening breathing problems that can lead to death. Breathing problems are more likely to occur in patients with underlying breathing problems, elderly patients, or impaired or weak patients. These problems usually occur after large initial doses in patients who are not opioid tolerant or when opioids are given with other medicines that slow breathing.

ABSTRAL is made with the prescription medicine fentanyl. Your healthcare provider will prescribe a starting dose of ABSTRAL that may be different than other fentanyl-containing medicines you may have been taking. Do not switch from ABSTRAL to other medicines that contain fentanyl without talking with your healthcare provider.

ABSTRAL is a federally controlled substance (CII) because it is a strong opioid (narcotic) pain medicine that can be misused by people who abuse prescription medicines or street drugs.

Never give ABSTRAL to anyone else, even if they have the same symptoms you have. It may harm them or cause death.

Do not take ABSTRAL for short-term pain that you would expect to go away in a few days, such as pain after surgery, headache, migraine, or dental pain.

Do not take ABSTRAL if you are allergic to any of the ingredients in ABSTRAL.

Tell your doctor about all of your medical and mental health problems. If you have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath, ABSTRAL may cause more serious breathing problems.

Do not take any medicine while using ABSTRAL until you have talked to your healthcare provider. Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers. Also, do not drink alcohol while using ABSTRAL.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABSTRAL affects you. ABSTRAL can make you sleepy. Ask your healthcare provider when it is ok to do these activities.

ABSTRAL is only available through a program called the ABSTRAL REMS program. To receive ABSTRAL, you must talk to your healthcare provider, understand the benefits and risks of ABSTRAL, agree to all of the instructions, and sign the Patient-Prescriber Agreement form.

You or a family member should call your healthcare provider or get emergency medical help right away if you:

  • Have trouble breathing
  • Have drowsiness with slowed breathing
  • Have shallow breathing (little chest movement with breathing)
  • Feel faint, very dizzy, confused, or have other unusual symptoms

These symptoms can be a sign that you have taken too much ABSTRAL or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not take any more ABSTRAL until you have talked to your healthcare provider.

ABSTRAL can cause your blood pressure to drop. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.

The most common side effects of ABSTRAL are nausea, sleepiness, and headache.

Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including ABSTRAL. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) while you are taking ABSTRAL.

Please see full Prescribing Information, including Boxed Warning.

About ProStrakan

ProStrakan Group plc is a rapidly growing specialty pharmaceutical company engaged in the development and commercialization of prescription medicines for the treatment of unmet therapeutic needs in major markets.

ProStrakan's head office is located in Galashiels, Scotland. The company's development capabilities are centered in Galashiels and Bedminster, New Jersey, U.S. Sales and marketing of ProStrakan's portfolio of products are handled by commercial subsidiaries in the UK, U.S., France, Germany, Spain, Italy and other EU countries.

You can learn more about the business at: www.prostrakan.com.

About Orexo

Orexo AB is a pharmaceutical company, focusing on development of new, patented drugs by combining well-documented substances with innovative technologies, and the development of new treatments for respiratory and inflammatory diseases.

Orexo has a broad and competitive late-stage product portfolio, including two marketed products,five products in clinical phase and two undergoing registration.

To date, Orexo has out-licensed the market rights for ABSTRAL for the U.S., the EU and Japan markets, the world-wide market rights for Sublinox (OX22) and OX-NLA, and launched an out-license and research collaboration with Boehringer Ingelheim regarding the development of a new class of drugs to treat pain and inflammation. Also, Orexo has established a Nordic sales force by entering into a joint venture with ProStrakan.

Orexo has its head office in Uppsala, Sweden, and is listed on the OMX Nordic Exchange Stockholm, Small Cap (ticker: ORX). Visitwww.orexo.com.

(1) Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41: 273-281.

SOURCE ProStrakan Group plc



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