October 8, 2007
IV ZYFLO- GREAT POTENTIAL IN ER, BUT WILL THEY MARKET IT WELL?
Analysis of:
Critical Therapeutics Initiates Phase II Clinical Trial for Zileuton Injection | www.pipelinereview.com
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Implications: Zyflo is a great drug in its oral fornmaulation with goiod efficacy but has failed because one has to take it multiple times a day and because one has to monitor liver function. This new IV formulation should be as effective in the ER setting, but hurdles include poor drug marketing by Critical Therapeuitcs in the past and competition from Merck who are also devleoping an IV LT Modifier.
Analysis: IV Zyflo, a leukotriene inhibitor. has great potential to improve symptoms and lung function for the 2 million people who present to the ER annually. SInce zyflo not only has a rational basis in asthma management (it prevents leukotrienes from being synthesized and LT's play a role in bronchoconstriction), and since oral zyflo has already been demonstrated to have efficacy in patients with asthma, it is expected that the IV formulation may have acute effects in patients who present to the ER with asthma exacerbations. This will be an excellent ancillary therapy when patients present with asthma to the ER, and I foresee all patients poresenting to the ER to receive it.
They will need to demonstrate not only lung function improvement, but also differntial improvemen tin discharge from ER and lenght of stay.
2 major impediments:
1) can they market it? They have had difficulty marketing zyflo oral tablets and who knows whether they will have the wherewithall to get thi into to ER
2) they face competition from Merck, who are developing their own IV leukotriene modfiier for acute asthma.
Analysis: IV Zyflo, a leukotriene inhibitor. has great potential to improve symptoms and lung function for the 2 million people who present to the ER annually. SInce zyflo not only has a rational basis in asthma management (it prevents leukotrienes from being synthesized and LT's play a role in bronchoconstriction), and since oral zyflo has already been demonstrated to have efficacy in patients with asthma, it is expected that the IV formulation may have acute effects in patients who present to the ER with asthma exacerbations. This will be an excellent ancillary therapy when patients present with asthma to the ER, and I foresee all patients poresenting to the ER to receive it.
They will need to demonstrate not only lung function improvement, but also differntial improvemen tin discharge from ER and lenght of stay.
2 major impediments:
1) can they market it? They have had difficulty marketing zyflo oral tablets and who knows whether they will have the wherewithall to get thi into to ER
2) they face competition from Merck, who are developing their own IV leukotriene modfiier for acute asthma.
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