Sepracor: positive safety data boost for Xopenex
15th November 2006
By Lisette Oversteegen
Sepracor has presented positive data for its short-acting beta-agonist Xopenex HFA.
A study demonstrating the safety of Xopenex in a scenario of short-acting beta-agonist (SABA) overdosing, a significant problem among asthma patients, should help to position Sepracor's asthma treatment among hydrofluoroalkane (HFA) inhalers. With the predicted expansion of the US SABA market after 2008, this important differentiation should help Xopenex to reach peak sales of $450 million.
'Content Sepracor's HFA-MDI (metered-dose inhaler) version of Xopenex was launched in December 2005 for the treatment or prevention of bronchospasms in adults, adolescents and children aged four and older with reversible obstructive airway disease, such as asthma. The study looked at safety parameters associated with overdosing and compared Xopenex HFA MDI, which contains only the R-isomer of albuterol, with a racemic albuterol HFA MDI.
The study showed that changes in mean heart rate following four, eight and 16 cumulative puffs were significantly higher for racemic albuterol compared with Xopenex HFA. Overdosing can be a considerable issue in this drug class, as patients whose asthma is not under control try to alleviate their symptoms with short-acting "reliever" medication. However, since the underlying inflammation remains untreated, it is difficult to control its symptoms, potentially resulting in an increased intake of relievers.
If Sepracor is able to demonstrate to physicians and patients that the safety features of Xopenex-HFA are superior to other HFA-albuterol products, then the drug may become the gold-standard therapy. The company may also be able to differentiate Xopenex HFA from its competitors by virtue of the positive pediatric data.
Sepracor has a strong incentive to improve Xopenex HFA's profile: from 2008, the Montreal Protocol requires all (usually generic and cheap) chlorofluorocarbons-based metered dose inhalers (CFC MDIs) to be replaced with (more expensive branded) hydro-fluoroalkane metered dose inhalers (HFA MDIs). In the US, there are only a few approved albuterol HFA MDIs, including Xopenex and products by Schering-Plough, GSK and Ivax/Teva on the market.
Datamonitor expects the CFC-HFA switch to expand the US albuterol market by more than 50% between 2005 and 2009. Because of its unique profile, Sepracor's inhaler is predicted to catch 30% of this rapidly growing market, resulting in total peak sales for the Xopenex franchise (nebules and MDI) of more than $1 billion.
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