TORONTO, Canada I June 27, 2014 I 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®). 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.
SOURCE: Revive Therapeutics
Post Views: 512
TORONTO, Canada I June 27, 2014 I 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®). 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.
SOURCE: Revive Therapeutics
Post Views: 512
