Revive Therapeutics Ltd. Announces Positive Results of REV-001 Phase 2A Proof-Of-Concept Study

Revive Therapeutics Ltd. (TSX VENTURE:RVV) ("Revive") announced today positive
results from the second-half of its Phase 2a proof-of-concept study (the
"Study") of REV-001 targeted for the treatment and/or prevention of
opioid-induced respiratory depression for patients with sleep apnea in a
post-operative setting. 


The purpose of the Study is to determine the effect of an oral dose of REV-001
on alfentanil-induced respiratory depression and analgesia. The results of the
Study indicate that a single dose of REV-001 may treat and/or prevent opioid
induced respiratory depression in a post-operative setting, without affecting
analgesia. The 16-patient, placebo-controlled, double-blind, randomized two-way
crossover trial was performed by one of the leading experts in the field,
Professor Dr. Albert Dahan, M.D., Ph.D., at the Leiden University Medical Center
in The Netherlands. Full results of the Study to be published.


The data from the second-half of the Study in the eight patients yielded the
following key findings:




--  Treatments with REV-001 was safe and well tolerated at the 50 mg dose,
    was not associated with serious adverse events, and there was no
    treatment-related discontinuations; 
--  A significant increase on respiratory drive as measured by inspired
    minute ventilation at an elevated expired PCO2 (VE55) of 36% (p = 0.039)
    by REV-001 as compared to placebo during high-dose alfentanil infusion
    induced respiratory depression; 
--  Treatments with REV-001 did not affect the opioids analgesic properties;
    and 
--  Treatments with REV-001 did not affect sedation. 



"Overall, this is a successful study showing the respiratory stimulatory effects
of REV-001, that now seems to have a novel target, that is reversal of
opioid-induced respiratory depression and a unique solution in a post-operative
setting," said Prof. Dr. Albert Dahan M.D., Ph.D., Principal Study Investigator
and Professor of Anesthesiology at the Leiden University Medical Center, The
Netherlands.


"I am very pleased with the successful completion of our first human clinical
trial and that we met our milestone for REV-001 on time and on budget. The
positive results of the REV-001 human clinical trial now positions the drug for
partnering discussions," said Fabio Chianelli, Revive's Chief Executive Officer.
"This achievement not only validates our ability to successfully repurpose drugs
for new indications, but also provides us with the opportunity to advance our
business development activities via licensing and acquisitions."


About Post-Operative Pain and Sleep Apnea

According to the National Center for Health Statistics, there are over 100
million surgeries performed annually in the United States with approximately 50%
of those requiring post-operative pain medication such as opioids. However,
opioids are known to raise serious concerns such as respiratory depression,
oxygen desaturation and other side effects such as constipation, nausea and
vomiting. Patients who have obstructive sleep apnea (OSA) are at a particular
risk of experiencing such negative side-effects from opioids. There are 18
million Americans with sleep apnea and the condition is exacerbated with age,
obesity, smoking and alcohol. According to an article titled "A Rude Awakening -
The Perioperative Sleep Apnea Epidemic" published in the New England Journal of
Medicine in June 2013, the risk of perioperative complications increase
substantially with those who have OSA. Hospitals must take into consideration
the financial implications that may become prevalent for patients who have OSA
in order to reduce the risk of adverse events, such as opioid-induced
respiratory depression. It has been estimated that between 29% and 41% are at
high risk of opioid-induced respiratory depression. (Source: Hanna MH et al.
Anesthesiology. 2005;102(4): 815-821 and Overdyk FK et al. Anesth Analg.
2007;105(2): 412-418). Currently, there are no approved drugs for OSA and the
only drug treatments to counter opioid-induced respiratory depression is to
administer opiate receptor antagonists such as naloxone (Narcan(R)). However,
those antagonists eliminate the analgesic activity of the opioid drug and thus
are rarely used by hospitals and healthcare facilities to prevent or treat
opioid-induced respiratory depression. According to the article "A Rude
Awakening - The Perioperative Sleep Apnea Epidemic", perioperative sleep apnea
in the United States has been considered as an 'Epidemic'.


About REV-001

REV-001 is the repurposing of the drug tianeptine, an old but unique
anti-depressant drug, which is marketed in Asia, parts of Europe and South
America. Despite its narrow geographic scope, the decades-long clinical
experience of tianeptine suggests much about its safety. In fact, tianeptine has
been shown to have substantial cardiovascular and other safety at both normal
doses and in overdose. (Source: Wilde, M. I. & Benfield, P. Drugs 49, 411-439
(1995)). More recently, in animal studies conducted by Revive, tianeptine was
shown for the first time to prevent opioid(morphine)-induced respiratory
depression in an animal model. The novel findings in Revive's animal studies
enabled Revive to apply for intellectual property protection covering the use of
tianeptine to treat respiratory depression.


About Revive Therapeutics Ltd.

Revive Therapeutics Ltd. is a Canadian public company (TSX VENTURE:RVV) focused
on acquiring, developing and commercializing treatments for major market
opportunities such as gout, post-operative pain, and rare diseases. Revive aims
to bring drugs to market by finding new uses for old drugs, also known as drug
repurposing, and improving the therapeutic performance of existing drugs for
underserved medical needs. Additional information on Revive is available at
www.revivethera.com.  


The information in this news release includes certain information and statements
about management's view of future events, expectations, plans and prospects that
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include, among others, Revive's stage of development, lack of any product
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without limitation, Revive's Filing Statement dated November 26, 2013 filed on
SEDAR on November 27, 2013. 

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changes in assumptions, changes in factors affecting such forward looking
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FOR FURTHER INFORMATION PLEASE CONTACT: 
Revive Therapeutics Ltd.
Fabio Chianelli
Chief Executive Officer
905-605-5535 (ext. 10)
[e-mail]
www.revivethera.com