CAYSTON (Aztreonam Lysine)

Question

Hello. We asked that our daughter benefit from Cayston®. Could you tell me wether the tests are conclusive and if the people who experienced it have felt some improvement?

Answer

Hello.
The product you mention with its commercial name is the Aztreonam Lysine (AZLI).
AZLI is an inhaled antibiotic with cycles of alternating 28-day period of treatment and period of 28 days without treatment. Studies in patients with Pseudomonas aeruginosa respiratory colonization have shown good safety and efficacy in the treatment group compared to untreated (placebo) one: improvement in FEV1 and quality of life scores, fewer respiratory exacerbations and hospitalizations. In order to authorize AZLI’s marketing, the French authorities are currently analyzing the results of a study comparing its effectiveness to that of an already marketed drug: the inhaled Tobramycin. The question is to determine wether the new drug provides "increased offered medical service ", i.e. if it provides a plus compared to already available Tobramycin.
Awaiting this authorization, AZLI can however be prescribed for adult patients by a hospital physician under very specific conditions named "derogation to purchase". The doctor has to consider it necessary because of the absence of other appropriate treatment. The prescription is transmitted by the hospital pharmacy to the competent agency wich makes the decision to give or not a “derogatory”agreement.
The opportunity of such requirement has to be seriously discussed with the physician in charge of the patient.
Best regards,
Gilles RAULT, MD

30.11.2010