Tolerability of cetrorelix in study Z-033 was very good, as evidenced by the absence of major differences to placebo with regard to both clinical adverse events or changes in laboratory parameters. The most frequently reported adverse experiences included hot flushes, nasopharyngitis, injection site pain, and headache, which is what was seen in the safety study Z-041. In particular, the incidence of hot flushes was lower than was seen in study Z-041 (see below), and they were also reported by patients randomized to placebo.
In the safety study Z-041, all patients received cetrorelix by intra-muscular (IM) injection at Weeks 0 and 2, and were followed up to Week 26. The primary endpoint was the incidence of possibly drug-related adverse events; efficacy parameters were evaluated as secondary endpoints. The study was conducted in 68 sites in the United States and Canada.
Cetrorelix was generally well tolerated. Adverse events were mostly mild and transient in intensity. Serious adverse events occurred in 12 patients, but none of these was assessed as possibly drug-related. The most frequently reported adverse experiences included hot flushes, nasopharyngitis, injections site pain, and headache. Hot flushes were reported by 49 patients and were mild and of short duration in the majority of patients. Only one patient experienced a severe episode. A questionnaire was used to assess the local tolerance of the IM injection and affirmed the acceptability of this route of administration.
Efficacy was assessed using the IPSS which showed an improvement from a mean score of 21.2 at baseline to 15.6 at Week 26. In 63% of the patients, the improvement was
|SOURCE AETERNA ZENTARIS INC.|
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