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). Visit
www.orexo.com.
(1) Portenoy RK, Hagen NA. Breakthrough pain: definition,
prevalence and characteristics. Pain. 1990;41: 273-281.
SOURCE ProStrakan Group plc