Meda Launches Onsolis(TM) (Fentanyl Buccal Soluble Film) for the Treatment of Breakthrough Cancer Pain in Opioid Tolerant Patients

Meda Launches Onsolis(TM) (Fentanyl Buccal Soluble Film) for the Treatment of
Breakthrough Cancer Pain in Opioid Tolerant Patients
Meda's FOCUS(TM) Program, First Opioid REMS Program, Designed to Facilitate
Appropriate Use of Onsolis

SOMERSET, N.J., Oct. 13 /PRNewswire/ -- Meda Pharmaceuticals Inc. today
announced the launch of Onsolis(TM)( )(fentanyl buccal soluble film) in the
U.S. for the management of breakthrough pain (BTP) in patients with cancer,
eighteen years of age and older, who are already receiving and who are
tolerant to opioid therapy for their underlying persistent cancer pain.
Onsolis uses an innovative drug delivery technology called BioErodible
MucoAdhesive (BEMA(TM)), developed by BioDelivery Sciences International, Inc.
(BDSI). Onsolis consists of a small, dissolvable, polymer film, formulated
with fentanyl, for application to the inner lining of the cheek.

Onsolis is available through a controlled distribution program called
FOCUS(TM) (Full Ongoing Commitment to User Safety), the first opioid Risk
Evaluation and Management Strategy (REMS) program that provides for
prescriber, pharmacy, and patient enrollment for the integrated, coordinated
safe use of Onsolis. The FOCUS Program was designed to meet requirements by
the U.S. Food and Drug Administration (FDA) to help ensure appropriate use of
Onsolis.

"The launch of Onsolis represents a significant achievement for Meda and an
innovative pain management option for physicians to offer their patients with
cancer who are experiencing breakthrough pain. The Onsolis technology differs
from existing products used in these patients by virtue of its physical
characteristics that enable patients to obtain the pain relief they need in a
convenient delivery system," said Sharon Clarke, President, Meda
Pharmaceuticals Inc. "We are proud of our work with the FDA on the development
of FOCUS, a program that is designed to facilitate the appropriate use of
Onsolis and to provide healthcare practitioners, patients, and caregivers with
comprehensive training and information."

The goal of the FOCUS Program for Onsolis is to lessen the risk of Onsolis
overdose, abuse, addiction, and serious complications due to medication errors
by:
-- Helping to assure proper patient selection, including avoidance of the
use of Onsolis in opioid non-tolerant patients;
-- Reducing the risk of exposure to Onsolis in persons for whom it was
not
prescribed, including accidental exposure in children; and

-- Training prescribers, pharmacists, and patients about proper dosing
and
administration.

Under the FOCUS Program, only prescribers, pharmacies, and patients registered
with the program are able to prescribe, dispense, and receive Onsolis. This
program provides educational materials, patient counseling and managed
distribution of the drug. Healthcare practitioners who wish to enroll in the
FOCUS Program may call 1-877-466-7654 (1-877-4ONSOLIS) or visit
www.OnsolisFocus.com.

Clinical Study
The efficacy of Onsolis was investigated in a clinical trial in opioid
tolerant adult patients experiencing breakthrough cancer pain. Breakthrough
cancer pain was defined as a transient flare of moderate-to-severe pain
occurring in patients with cancer experiencing persistent cancer pain
otherwise controlled with maintenance doses of opioid medications including at
least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour, or an
equianalgesic dose of another opioid for one week or longer. All patients were
on stable doses of either long-acting oral opioids or transdermal fentanyl for
their persistent cancer pain.

A double-blind, placebo-controlled, crossover study was performed in patients
with cancer to evaluate the effectiveness of Onsolis for the treatment of
breakthrough cancer pain. Open-label titration identified a successful dose of
Onsolis, within the range of 200 to 1200 mcg. A "successful" dose was defined
as a dose in which a patient obtained adequate analgesia with tolerable side
effects. In the double-blind portion of the study, patients who identified a
successful dose were randomized to a sequence of nine treatments; six with the
successful dose of Onsolis and three with placebo. Of the patients who entered
the study, 54 percent achieved a successful dose during the titration phase
and 4 percent withdrew for lack of effective pain relief. The final titrated
dose of Onsolis for breakthrough cancer pain was not predicted from the daily
maintenance dose of opioid used to manage the persistent cancer pain and,
therefore, the dose was determined by titration starting at 200 mcg. The
primary outcome measure, the mean sum of pain intensity differences at 30
minutes (SPID30) for Onsolis-treated episodes was statistically significantly
higher than for placebo-treated episodes.

About Onsolis
Onsolis is a small, dissolvable, polymer film, formulated with the opioid
fentanyl for application to the buccal mucosa (inner lining of the cheek) that
is designed to deliver a dose of drug across the oral mucous membranes.
Fentanyl belongs to the group of medicines called narcotic analgesics, which
are used to relieve pain. Onsolis was evaluated in over 300 patients; over
90,000 doses were administered in clinical trials. Onsolis adheres to the
buccal mucosa in 5 seconds, starts to dissolve in 15 to 30 minutes and
delivers fentanyl across the mucosa. In clinical trials, following buccal
application of Onsolis in healthy volunteers, the absolute bioavailability of
fentanyl was 71%.

About Breakthrough Pain in Cancer
Breakthrough Pain (BTP) in cancer is a transitory, severe, or excruciating
pain flare-up that "breaks through" the relief provided by around-the-clock
analgesics. Unlike persistent cancer pain, BTP is generally rapid in onset
(within three minutes) and lasts up to two hours. A large multicenter survey
conducted by pain specialists in twenty-four countries found that 65% of 1,095
cancer patients had BTP. It is estimated that over a half-million people in
the U.S. with cancer suffer from breakthrough pain, however, only about twenty
thousand receive a treatment approved for the condition.

IMPORTANT SAFETY INFORMATION
Onsolis (fentanyl buccal soluble film) is an opioid analgesic indicated only
for the management of breakthrough pain in patients with cancer, 18 years of
age and older, who are already receiving and who are tolerant to opioid
therapy for their underlying persistent cancer pain. Patients considered
opioid tolerant are those who are taking at least: 60 mg oral morphine/day, 25
mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral
hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of
another opioid for one week or longer.

Onsolis is contraindicated in opioid non-tolerant patients; in the treatment
of acute or postoperative pain, including headache/migraine, dental pain, or
use in the emergency room; and in patients with intolerance or
hypersensitivity to fentanyl, Onsolis, or its components. Life-threatening
respiratory depression could occur in patients not taking chronic opiates.

Onsolis contains fentanyl, a Schedule II controlled substance with abuse
liability similar to other opioid analgesics.

Clinically significant respiratory and CNS depression can occur; patients
should be monitored accordingly. Onsolis films contain medicine in an amount
that can be fatal to a child. Keep out of the reach of children and dispose of
unneeded films properly. Use with other CNS depressants or CYP3A4 inhibitors
may increase depressant effects including hypoventilation (which may lead to
potentially fatal respiratory depression), hypotension, and profound sedation;
dosage adjustments may be warranted. Onsolis may impair ability for the
performance of potentially dangerous tasks (e.g., driving a car or operating
machinery). Onsolis should be titrated cautiously in patients with chronic
obstructive pulmonary disease or preexisting medical conditions predisposing
them to hypoventilation. Onsolis should be administered with extreme caution
in patients susceptible to intracranial effects of CO2( )retention.

Substantial differences exist in the pharmacokinetic profile of Onsolis
compared to other fentanyl products that result in clinically important
differences in the extent of absorption of fentanyl. As a result of these
differences, the substitution of Onsolis for any other fentanyl product may
result in fatal overdose.

The most common adverse reactions (frequency greater than or equal to 10%)
seen in Onsolis clinical trials were: nausea, vomiting, dizziness,
dehydration, dyspnea, and somnolence.

Safety and efficacy below age 18 years have not been established. Onsolis
should be administered with caution to patients with renal or hepatic
impairment.

Please see full prescribing information available at www.Onsolis.com.

For more information, contact Anders Larnholt, VP Corporate Development &
Investor Relations at anders.larnholt@meda.se or +46 709 458 878.

MEDA AB (publ) is a leading international specialty pharma company. Meda's
products are sold in 120 countries worldwide and the company is represented by
its own organizations in more than 40 countries. The Meda share is listed
under Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. Find out
more, visit www.meda.se.

SOURCE Meda Pharmaceuticals Inc.

Media, Mike Beyer of Sam Brown Inc., +1-773-463-4211, beyer@sambrown.com; or
Anders Larnholt, VP Corporate Development & Investor Relations of Meda AB, +46
709 458 878, anders.larnholt@meda.se