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Drawbridge Pharmaceuticals Release: Why We Need A New Drug For Anaesthesia: Survey


3/3/2014 9:43:03 AM

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3 March 2014 -- Drawbridge Pharmaceuticals Pty Ltd (Drawbridge) recently conducted an international survey of 160 anaesthetists on clinically relevant improvements for anaesthetic drugs and their cost—providing invaluable insight into the market need for new anaesthetic drugs.

The current market
The anaesthesia drugs market in the US is forecast to reach $7 billion by 2015. More than 80 million procedures that require general anaesthesia are performed annually in the United States and Europe alone and there is a continued trend to these involving a higher proportion of more ill patients in the very young and older age groups. This has highlighted the need for safer anaesthetic and sedative drugs.

Propofol is currently seen as the gold standard in anaesthesia—the preferred agent for the overwhelming majority of all cases of surgery, procedural sedation and intensive care sedation. It is sold cheaply as a generic drug. However, this low price combined with difficulties in manufacturing associated with its lipid formulation, has led to significant shortages of supplies particularly in the United States where anaesthetists have been forced to use older drugs with much less favourable pharmacodynamic and pharmacokinetic profiles.

In addition to ongoing supply issues, propofol has some significant issues with its use. The lipid base used in the propofol preparation is easily contaminated, supports bacterial growth, is incompatible with plastic containers and it leads to lipid toxicity. Propofol also causes cardiovascular depression with significant falls in blood pressure, particularly in the elderly, as well as respiratory depression and pain on injection.

Pharmaceutical companies worldwide are working to develop a new intravenous anaesthetic to complement or replace propofol. Drawbridge Pharmaceuticals is currently developing Phaxan™—a novel water based formulation of alphaxalone that has none of the lipid issues associated with propofol. Phaxan™ has a wider therapeutic index and improved cardiovascular stability compared with propofol with as rapid onset and offset of action.

Survey highlights the need for an alternative anaesthetic
The survey was completed by 160 anaesthetists worldwide to investigate the properties of an anaesthetic that would prompt them to consider changing from propofol to the alternative intravenous anaesthetic they would use by bolus injection and infusion. Questions were prepared to ensure that respondents were not aware that the properties described as the ‘new alternative’ anaesthetic to propofol was referring to any particular compound.

According to the survey, 43 percent of respondents were likely to choose the alternative anaesthetic provided it had onset and offset times equal with propofol. However, this increased to 96.5 percent if the new anaesthetic was shown to have a much higher therapeutic index than propofol.

“Phaxan™ has been shown to be six times less toxic than propofol with a therapeutic index of 30 compared with 5 for propofol; so it will be seen as a much safer alternative to propofol for anaesthesia,” said Prof. Colin Goodchild, Chief Medical Officer at Drawbridge Pharmaceuticals.

Cardiovascular stability during anaesthesia proved to be an important factor for anaesthetists in choosing an intravenous anaesthetic drug, with 93 percent of respondents likely to use the alternative anaesthetic if it caused significantly less depression of blood pressure than propofol.

The survey also showed that 77 percent of respondents were likely to use the alternative anaesthetic based on the fact that it has a water based formulation and so avoiding the infection issues associated with propofol, which have been well-documented in the press and well-known within the FDA over the last few years.

When a price of ten dollars per dose for the new agent was put into the equation significantly more anaesthetists said that they would still use the new agent when they had patients presenting for anaesthesia in the following common clinical situations:

• An elderly patient with heart disease — approximately 83 percent were likely to purchase the new anaesthetic
• An elderly patient with early cognitive decline — 67 percent were likely to purchase the new anaesthetic on the understanding that there was evidence that the new anaesthetic could protect such brains when other agents do not
• A patient with severe respiratory disease — approximately 57 percent would be likely to buy the new anaesthetic
• A case of multi trauma — 74 percent were likely to purchase the new anaesthetic on the basis that the new agent is cerebrally protective with better cardiovascular stability than propofol
• A case of neurotrauma, in anaesthesia for neurosurgery, or ICU management of stroke or head injury — 87 percent of respondents were likely to use the new agent where the dose of propofol required is well-known to cause problematic cardiovascular depression
• Approximately 95 percent of respondents were likely to use the new alternative agent if it caused neuroprotection in conditions that cause neural stress such as sepsis, pain and trauma.

According to Dr Anthony Filippis, Chief Executive Officer at Drawbridge Pharmaceuticals, “This survey highlights the market need for a new anaesthetic that addresses the shortfalls and limitations of propofol.”

“We’re looking forward to seeing Phaxan™ being developed further and eventually introduced in the clinic as an alternative intravenous anaesthetic. We’re currently conducting a clinical trial comparing the anaesthetic properties of Phaxan™ with propofol. We will be looking to partner with a pharmaceutical company to further the development of Phaxan™.”

The full detailed report of the results of the survey can be viewed at: http://www.drawbridgepharmaceuticals.com.au/attachments/Survey_of_Anesthesiologists_re_propofol_v_Phaxan.pdf

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

About Phaxan™
Phaxan™ is a novel water based formulation of the neuroactive steroid, alphaxalone. It has a wide therapeutic index and 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 is superior to propofol in preclinical models.

Phaxan™ is a registered trade mark 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 enquiries:
Christine Filippis, Mendleson Communication: ph (03) 9421 6520, email christine@mendleson.com.au

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