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What are the adverse effects of Fezonastat?
The US FDA approved Veozah (fezolinetant) on May 12, 2023, for the treatment of moderate to severe vasomotor symptoms (hot flashes) in perimenopausal women. Veozah (CAS registration number 1629229-37-3, molecular formula C.H FN, OS) is an NK3 (neurokinin 3/neurokinin 3) receptor antagonist. NK3 receptors play an important role in regulating body temperature in the human brain. Veozah is the first NK3 receptor antagonist drug approved by the FDA for the treatment of hot flashes in perimenopausal women. So, what are the adverse effects of filzonetant?
Adverse reactions of Fezonatant
Because clinical trials are conducted under a variety of different conditions, the incidence observed in the clinical trials of one drug cannot be directly compared to the incidence in the clinical trials of another drug or reflect the incidence observed in clinical practice.
The safety of VEOZAH was evaluated in three 52-week clinical trials. A total of 1,100 women received VEOZAH in 3 projects. Trials 1 and 2 were placebo-controlled for the first 12 weeks, after which women who had previously received placebo were rerandomized to VEOZAH (women who received VEOZAH continued to receive VEOZAH) for an additional 40 weeks of uncontrolled treatment. Trial 3 was a randomized, placebo-controlled, double-blind safety study evaluating the safety of VEOZAH treatment for 52 weeks. Adverse reactions reported by at least 2% of patients in the VEOZAH 45 mg group and higher than those in the placebo group in Trial 3 are shown in Table 1.
Table 1: Adverse reactions reported by at least 2% of patients in the VEOZAH 45 mg group and greater than those in the placebo group in the placebo-controlled, double-blind 52-week trial (Trial 3)
|
Adverse reactions |
VEOZAH 45 mg(n = 609) Total person-years = 504.2 n(%, EAIR 1) |
Placebo (n = 610) Total person-years = 475.0 n(%, EAIR 1) |
|
Abdominal pain2 |
26 (4.3%, 5.2) |
13 (2.1%, 2.7) |
|
Diarrhea |
24 (3.9%, 4.8) |
16 (2.6%, 3.4) |
|
insomnia |
24 (3.9%, 4.8) |
11 (1.8%, 2.3) |
|
back pain |
18 (3.0%, 3.6) |
13 (2.1%, 2.7) |
|
hot flashes |
15 (2.5%, 3.0) |
10 (1.6%, 2.1) |
|
Elevated liver transaminases3 |
14 (2.3%, 2.8) |
5 (0.8%, 1.1) |
In pooled laboratory data from Trials 1, 2, and 3, 25 women (2.3%, 2.7 EAIR) (n = 1100, 912.1 total person-years) exposed to VEOZAH 45 mg and 8 women (0.9%, 1.5 EAIR) (n = 952, 549.1 total person-years) exposed to placebo developed hepatic transaminase elevations (greater than 3 times the ULN).
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