Drawbridge Pharmaceuticals Moves Phaxan Forward
•Translation of Phaxan™ from concept to clinic
•Clinical paper accepted for publication in prominent medical journal: Anesthesia and Analgesia
•Prefaced by two editorials
MELBOURNE, AUSTRALIA: May 4th, 2015—Drawbridge Pharmaceuticals Pty Ltd (Drawbridge) is pleased to announce that the Phase 1c proof of concept clinical trial of Phaxan™ has been accepted for publication in the prestigious medical journal Anesthesia and Analgesia.
The paper titled, A Phase 1c Trial Comparing Efficacy and Safety of a New Aqueous Formulation of Alphaxalone with Propofol, contains the full results of the trial, which was completed in April 2014 and presented at Anesthesiology™ 2014 in New Orleans, LA. The article will be published ahead of print in the next few weeks and then available for download.
The paper details the successful outcome of the randomised, double blind dose finding; the first study in humans comparing the anaesthetic properties of Phaxan™ with propofol. The results clearly confirm in man all of the preclinical results with Phaxan™- showing that Phaxan™ is as fast as propofol in onset and offset of intravenous anaesthesia with improved cardiovascular and respiratory safety.
The acceptance of the clinical trial paper by Anesthesia and Analgesia coincides with publication of the results of the preclinical studies on Phaxan™ in the same journal: Alphaxalone Reformulated: A Water-Soluble Intravenous Anesthetic Preparation in Sulfobutyl-Ether ß-Cyclodextrin [Anesth Analg 2015;120:1025–311.
“We are pleased that a prestigious journal like Anesthesia and Analgesia that is widely-read and cited, has decided to publish both papers which show the progression of Phaxan™ from concept to clinic,” said Professor Colin Goodchild, Chief Medical Officer at Drawbridge Pharmaceuticals."
Drawbridge’s articles are also accompanied by two editorials in the same edition of the Journal that highlight the translation of the properties of Phaxan™ described in the preclinical studies into the proof of concept clinical study in humans. A summary of the key points of these editorials can be found below. According to Dr Anthony Filippis, CEO at Drawbridge Pharmaceuticals, “Ever since the analysis of the results of our survey of anaesthetists’ opinions of the need for a new and safer alternative to propofol, we have been confident that Phaxan™ would fulfil this role. Publication of the two seminal papers that signify the translation of Phaxan™ from concept to clinic, endorses our goals of continued commercial development of Phaxan™ towards widespread use in all critical care areas.”
About the editorials
The first editorial, entitled Another Steroid Hypnotic: More of the Same or Something Different? 2 by Professors M. Hollmann and John Sear catalogues the history and advantages over other anaesthetic drugs of past steroid anaesthetic compounds. They conclude by saying "Many anesthesiologists in Europe and Australasia lamented the passing of Althesin" [note inserted: Althesin was the previous formulation of alphaxalone formulated in Cremophor which was withdrawn from the market because of hypersensitivity reactions to the Cremophor]. "In the interim, propofol supplanted the other IV hypnotics and has been uniformly adopted as the IV hypnotic of choice worldwide. We await further animal and human studies before seeing if a reformulated alfaxalone has a potential role in the future of anesthesia."
In the other editorial entitled Steroid Anesthesia Revisited: Again 3 Kharasch and Hollmann, when talking about neurosteroid anaesthetics, including alphaxalone, state: "The major problem was the formulation of these highly lipid soluble (and hence water-insoluble) compounds for IV administration. Nevertheless, neurosteroids possess many characteristics of the “ideal” anesthetic." and further they conclude: "The search for an ideal anesthetic continues. Based on the results of the initial experiments by Goodchild et al., it appears that alphaxalone-cyclodextrin may be a better alphaxalone than alphaxalone-Cremophor. The more interesting question is whether alphaxalone-cyclodextrin [Phaxan™] will be a better anesthetic than propofol."
Taken together, these two editorials link the preclinical and clinical papers on Phaxan™ perfectly, highlighting the translation of the properties of Phaxan™ described in the preclinical studies into the proof of concept clinical study in humans. Together, these studies have established that Phaxan™, a water-based formulation of alphaxalone, has a similar onset and offset of sedation to propofol and a rapid recovery in cognitive function. Most importantly, unlike propofol, Phaxan™ caused no pain on injection or emergence delirium which clearly shows that Phaxan™ has the potential to match propofol in performance as a fast onset, short acting, intravenous anaesthetic but with greater safety and patient comfort.
References
1. Goodchild CS, Serrao JM, Kolosov A, Boyd BJ. Alphaxalone reformulated: a water-soluble intravenous anesthetic preparation in sulfobutyl-ether-beta-cyclodextrin. Anesth Analg 2015;120:1025–31
2. Hollmann MW, Sear JW. Another Steroid Hypnotic: More of the Same or Something Different? Anesth Analg 2015;120(5):980-982
3. Kharasch ED, Hollmann MW. Steroid Anesthesia Revisited: Again. Anesth Analg 2015; 120(5): 983-984
About Drawbridge Pharmaceuticals
Drawbridge Pharmaceuticals was founded in 2011. It is a privately-held biotechnology company, headquartered in Melbourne, Australia. The company is developing innovative neuroactive steroid compounds for use in critical care situations. Phaxan™ is the lead compound for use as a fast onset and offset intravenous general anaesthetic and sedative.
www.drawbridgepharmaceuticals.com.au
https://twitter.com/DrawbridgePharm
About Phaxan™
Phaxan™ is a novel water based formulation of the neuroactive steroid, alphaxalone. It has a wide therapeutic index, the widest ever described for any anaesthetic compound. Phaxan™ is an efficacious intravenous anaesthetic with rapid onset and offset of action. The anaesthetic agent in Phaxan™ has been administered in the past as Althesin® when formulated in a different excipient. It was withdrawn in 1984 because of problems with the formulation. Phaxan™ does not have the problems of the Althesin® formulation and it’s superiority in safety compared with propofol, has been demonstrated in preclinical and clinical trials.
Phaxan™ is a registered trademark for alphaxalone formulated in sulfobutyl ether beta cyclodextrin being developed by Drawbridge Pharmaceuticals.
Dr Anthony Filippis and Prof. Colin Goodchild are available for interviews
Media contact:
Christine Filippis
Teraze Communications
E:christine@teraze.com.au
T:+61 3 8391 0701
M:+61 419 119 866
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•Clinical paper accepted for publication in prominent medical journal: Anesthesia and Analgesia
•Prefaced by two editorials
MELBOURNE, AUSTRALIA: May 4th, 2015—Drawbridge Pharmaceuticals Pty Ltd (Drawbridge) is pleased to announce that the Phase 1c proof of concept clinical trial of Phaxan™ has been accepted for publication in the prestigious medical journal Anesthesia and Analgesia.
The paper titled, A Phase 1c Trial Comparing Efficacy and Safety of a New Aqueous Formulation of Alphaxalone with Propofol, contains the full results of the trial, which was completed in April 2014 and presented at Anesthesiology™ 2014 in New Orleans, LA. The article will be published ahead of print in the next few weeks and then available for download.
The paper details the successful outcome of the randomised, double blind dose finding; the first study in humans comparing the anaesthetic properties of Phaxan™ with propofol. The results clearly confirm in man all of the preclinical results with Phaxan™- showing that Phaxan™ is as fast as propofol in onset and offset of intravenous anaesthesia with improved cardiovascular and respiratory safety.
The acceptance of the clinical trial paper by Anesthesia and Analgesia coincides with publication of the results of the preclinical studies on Phaxan™ in the same journal: Alphaxalone Reformulated: A Water-Soluble Intravenous Anesthetic Preparation in Sulfobutyl-Ether ß-Cyclodextrin [Anesth Analg 2015;120:1025–311.
“We are pleased that a prestigious journal like Anesthesia and Analgesia that is widely-read and cited, has decided to publish both papers which show the progression of Phaxan™ from concept to clinic,” said Professor Colin Goodchild, Chief Medical Officer at Drawbridge Pharmaceuticals."
Drawbridge’s articles are also accompanied by two editorials in the same edition of the Journal that highlight the translation of the properties of Phaxan™ described in the preclinical studies into the proof of concept clinical study in humans. A summary of the key points of these editorials can be found below. According to Dr Anthony Filippis, CEO at Drawbridge Pharmaceuticals, “Ever since the analysis of the results of our survey of anaesthetists’ opinions of the need for a new and safer alternative to propofol, we have been confident that Phaxan™ would fulfil this role. Publication of the two seminal papers that signify the translation of Phaxan™ from concept to clinic, endorses our goals of continued commercial development of Phaxan™ towards widespread use in all critical care areas.”
About the editorials
The first editorial, entitled Another Steroid Hypnotic: More of the Same or Something Different? 2 by Professors M. Hollmann and John Sear catalogues the history and advantages over other anaesthetic drugs of past steroid anaesthetic compounds. They conclude by saying "Many anesthesiologists in Europe and Australasia lamented the passing of Althesin" [note inserted: Althesin was the previous formulation of alphaxalone formulated in Cremophor which was withdrawn from the market because of hypersensitivity reactions to the Cremophor]. "In the interim, propofol supplanted the other IV hypnotics and has been uniformly adopted as the IV hypnotic of choice worldwide. We await further animal and human studies before seeing if a reformulated alfaxalone has a potential role in the future of anesthesia."
In the other editorial entitled Steroid Anesthesia Revisited: Again 3 Kharasch and Hollmann, when talking about neurosteroid anaesthetics, including alphaxalone, state: "The major problem was the formulation of these highly lipid soluble (and hence water-insoluble) compounds for IV administration. Nevertheless, neurosteroids possess many characteristics of the “ideal” anesthetic." and further they conclude: "The search for an ideal anesthetic continues. Based on the results of the initial experiments by Goodchild et al., it appears that alphaxalone-cyclodextrin may be a better alphaxalone than alphaxalone-Cremophor. The more interesting question is whether alphaxalone-cyclodextrin [Phaxan™] will be a better anesthetic than propofol."
Taken together, these two editorials link the preclinical and clinical papers on Phaxan™ perfectly, highlighting the translation of the properties of Phaxan™ described in the preclinical studies into the proof of concept clinical study in humans. Together, these studies have established that Phaxan™, a water-based formulation of alphaxalone, has a similar onset and offset of sedation to propofol and a rapid recovery in cognitive function. Most importantly, unlike propofol, Phaxan™ caused no pain on injection or emergence delirium which clearly shows that Phaxan™ has the potential to match propofol in performance as a fast onset, short acting, intravenous anaesthetic but with greater safety and patient comfort.
References
1. Goodchild CS, Serrao JM, Kolosov A, Boyd BJ. Alphaxalone reformulated: a water-soluble intravenous anesthetic preparation in sulfobutyl-ether-beta-cyclodextrin. Anesth Analg 2015;120:1025–31
2. Hollmann MW, Sear JW. Another Steroid Hypnotic: More of the Same or Something Different? Anesth Analg 2015;120(5):980-982
3. Kharasch ED, Hollmann MW. Steroid Anesthesia Revisited: Again. Anesth Analg 2015; 120(5): 983-984
About Drawbridge Pharmaceuticals
Drawbridge Pharmaceuticals was founded in 2011. It is a privately-held biotechnology company, headquartered in Melbourne, Australia. The company is developing innovative neuroactive steroid compounds for use in critical care situations. Phaxan™ is the lead compound for use as a fast onset and offset intravenous general anaesthetic and sedative.
www.drawbridgepharmaceuticals.com.au
https://twitter.com/DrawbridgePharm
About Phaxan™
Phaxan™ is a novel water based formulation of the neuroactive steroid, alphaxalone. It has a wide therapeutic index, the widest ever described for any anaesthetic compound. Phaxan™ is an efficacious intravenous anaesthetic with rapid onset and offset of action. The anaesthetic agent in Phaxan™ has been administered in the past as Althesin® when formulated in a different excipient. It was withdrawn in 1984 because of problems with the formulation. Phaxan™ does not have the problems of the Althesin® formulation and it’s superiority in safety compared with propofol, has been demonstrated in preclinical and clinical trials.
Phaxan™ is a registered trademark for alphaxalone formulated in sulfobutyl ether beta cyclodextrin being developed by Drawbridge Pharmaceuticals.
Dr Anthony Filippis and Prof. Colin Goodchild are available for interviews
Media contact:
Christine Filippis
Teraze Communications
E:christine@teraze.com.au
T:+61 3 8391 0701
M:+61 419 119 866
Help employers find you! Check out all the jobs and post your resume.