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2014-06-24

Orexo: Top-line data from a Phase 3 clinical trial demonstrates that Zubsolv® is as effective as Suboxone® film in the treatment of opioid dependence

Uppsala, Sweden - June 25, 2014 - Orexo announces top-line data from a
Phase 3 clinical trial demonstrating that Zubsolv®
(buprenorphine/naloxone CIII sublingual tablet) is as effective as
Suboxone® film in the treatment of opioid dependence. The results
from a randomized, non-inferiority, multicenter, comparative trial
(N=758) establish that, despite a 29 % lower dose, Zubsolv provides
equivalent efficacy compared to Suboxone film in patients who are
opioid dependent. The Induction, STabilization, Adherence and
Retention Trial (ISTART) (Study OX219-006), sponsored by Orexo, was
the largest trial ever conducted with buprenorphine (N=758).

The primary endpoint of the ISTART study was retention in treatment at
Day 15 with Zubsolv and Suboxone film. The study showed that there
was no difference in retention in treatment at Day 15 [Zubsolv arm:
83% (273/329); Suboxone film arm: 82.5% (269/326)]. As previously
announced an additional co-primary endpoint assessed Zubsolv as a
treatment for induction of buprenorphine maintenance therapy compared
to generic buprenorphine monotherapy. There was no difference in
retention at Day 3 [Zubsolv arm: 93.3% (309/329); generic
buprenorphine arm: 92.6% (302/326)] in the per protocol set.

Similar improvements for both groups were observed in Clinical Opiate
Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS),
and opioid cravings VAS total scores. Physicians and patients, using
the Clinical Global Impression (CGI-I) and Patient Global Impression
(PGI-I) Improvement scales, reported that both treatments resulted in
an average score of "much improved" from baseline at study end.

"The ISTART study confirms Zubsolv is appropriate and effective for
maintenance treatment of patients with opioid dependence," said Erik
Gunderson, MD, FASAM, the principle investigator of the study. "When
you consider that Zubsolv with a 29% lower dose has similar efficacy
to Suboxone film, a preferred taste, child-resistant packaging, and
fast dissolve time, physicians have an important alternative
treatment option in the fight against this public health epidemic."

Nikolaj Sorensen, Chief Executive Officer of Orexo, noted, "This is
another example of Orexo's commitment in advancing the treatment of
opioid dependence for the patients who suffer from this disease and
in supporting the physicians who treat them. To our knowledge, this
is the largest clinical trial ever conducted to assess buprenorphine
for the treatment of opioid dependence. These data provide evidence
that Orexo's advanced formulation technology is medically meaningful
and we are proud to offer a product that is efficacious, convenient
and safe at a lower dose, decreasing the amount of buprenorphine
available for diversion. Finally, this comprehensive study indicates
that a good clinical outcome can be obtained using Zubsolv for
induction treatment followed by maintenance treatment. With this data
all physicians should feel comfortable offering and switching their
patients suffering from opioid dependence to Zubsolv from their
existing treatment with buprenorphine and naloxone".

For further information, please contact:
Nikolaj Sorensen, President and CEO
Tel: +46 (0)703-50 78 88, E-mail: ir@orexo.com

About the ISTART Trial
The IStart Trial was a randomized, non-inferiority, multicenter study
to assess early treatment efficacy of Zubsolv versus SUBOXONE film
and to explore switching between treatments. The primary endpoints
were retention in treatment at Day 15 and Day 3. Secondary efficacy
assessments included scores on the COWS and SOWS, and opioid cravings
VAS, CGI and PGI improvement from baseline, and switching between
Zubsolv and Suboxone film. 758 opioid dependent adult subjects were
randomized. On days 1 and 2, patients received a blinded, fixed dose
of Zubsolv (5.7/1.4 mg and 5.7/1.4 or 11.4/2.8 mg, respectively) or
generic buprenorphine monotherapy (8 mg and 8 or 16 mg,
respectively). On Day 3, the patients on generic buprenorphine were
switched to Suboxone film and patients in the Zubsolv arm continued
to receive Zubsolv. Stabilization doses were titrated to a maximum
daily dose of 17.1/4.2 mg and 24/6 mg for Zubsolv and Suboxone film,
respectively, based upon clinical symptoms.

About Orexo AB
Orexo is a specialty pharma company with commercial operations in the
United States and R&D in Sweden developing improved treatments using
proprietary drug delivery technology and commercial operations in the
United States. The company is commercializing its proprietary
product, Zubsolv®, for maintenance treatment of opioid dependence, in
the United States. Zubsolv is a novel formulation of buprenorphine
and naloxone using Orexo's extensive knowledge in sublingual
technologies. Orexo has a portfolio of two approved and revenue
generating products currently marketed under license in the EU and
US. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ
OMX Stockholm Exchange and its American Depositary Receipts (ADRs)
trade on the OTCQX marketplace in the U.S. under the symbol, "ORXOY".
The largest shareholders are Novo A/S and HealthCap.

For information about Orexo, please visit www.orexo.com

About Zubsolv®
Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII) is
indicated for the maintenance treatment of opioid dependence and
should be used as part of a comprehensive treatment plan, which
includes counseling and psychosocial support. Treatment should be
initiated under the direction of physicians who are certified under
the Drug Addiction Treatment Act of 2000, and who have been assigned
a unique identification number ("X" number).

Zubsolv sublingual tablets can be abused in a manner similar to other
opioids, legal or illicit. Clinical monitoring appropriate to the
patient's level of stability is essential. Liver function tests
should be monitored before and during treatment. Children who take
Zubsolv sublingual tablets can have severe, possibly fatal,
respiratory depression. Emergency medical care is critical. Keep
Zubsolv sublingual tablets out of the sight and reach of children.

Adverse events commonly observed with the sublingual administration of
buprenorphine/naloxone sublingual tablets during clinical trials and
post-marketing experience are headache, nausea, vomiting,
hyperhidrosis, constipation, signs and symptoms of withdrawal,
insomnia, pain and peripheral edema.

Further information on Zubsolv can be found at www.zubsolv.com.

Suboxone is a registered trademark of Reckitt Benckiser Healthcare
(UK) Ltd.

Orexo AB (publ) discloses the information provided herein pursuant to
the Financial Instruments Trading Act and/or the Securities Markets
Act. The information was submitted for publication at 8:30 am CET on
June 25, 2014.

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http://news.cision.com/orexo/r/top-line-data-from-a-phase-3-clinical-tri...
http://mb.cision.com/Main/694/9607099/260117.pdf

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