Evaluating clinical trial data for Gefapixant Citrate

Gefapixant Citrate (Gefapixant Citrate) is a new antitussive drug specially used to treat refractory or unexplained chronic cough in adults. With the gradual promotion of Gemfapixin worldwide, the evaluation of its clinical efficacy has gradually become the focus of attention of the medical community. Its main clinical trial results come from two large, randomized controlled studies, which were designed to verify the therapeutic effect of gemfapixin in patients with chronic cough and its superiority compared with placebo.

The two studies recruited a total of 1,360 adults with chronic cough. Participants were randomly assigned to receive either gemfapixin or placebo for 12 and 24 weeks, respectively. According to the design of these studies, the primary measure was the patient's change in the number of coughs per hour as a direct reflection of drug efficacy.

1. The first study (12-week treatment period)

In the first study, after 12 weeks of treatment, the number of coughs per hour in patients in the Gemfapixin group dropped from 18.2 times to 7.1 times, a decrease of 61%. In contrast, patients in the placebo group experienced a 55% decrease in coughs per hour from 22.8 to 10.3. This result shows that Gemfapixen has a significant advantage over placebo in reducing cough frequency. Not only did patients in the treatment group cough less often, but their cough severity also improved, and patients' self-assessment results and quality of life also showed positive changes.

In addition, the study also showed that the therapeutic effect of Gemfapixin remained stable throughout12 weeks, and no obvious drug resistance occurred. Relatively speaking, the efficacy of the placebo group was more limited. Although the patient's cough frequency was reduced, the difference was significant compared with the gemfapixin group. These data reinforce the potential of gemfapixin as a treatment for chronic cough, especially in patients who do not respond well to conventional treatments.

2. The second study (24-week treatment period)

The second study had a longer treatment period24 weeks. The results showed that the number of coughs per hour in patients treated with Gemfapixin dropped from 18.6 times to 6.8 times, a decrease of 63%. In the placebo group, the number of coughs per hour dropped from 19.5 to 8.3, a decrease of 57%. The results of this study further verified the long-term efficacy of Gemfapixin, whose effects were sustained and stable within 24 weeks. In addition, the treatment group showed better results than the placebo group in multiple assessments, further supporting the effectiveness of Gemfapixin in treating chronic cough.

The treatment period of up to 24 weeks allows researchers to observe the efficacy and safety of the drug after long-term use. Gemfapixin did not show significant side effects or drug resistance during this process. Overall, the therapeutic effect of Gemfapixin gradually strengthens and can remain effective for a long time, making it a treatment option with great potential.

A combined evaluation of these two major studies demonstrates the significant efficacy of gemfapixin in the treatment of chronic cough. Gemfapixin can not only effectively reduce the frequency of cough, but also improve the patient's quality of life. Compared with the placebo group, the number of coughs in the treatment group was significantly reduced, and the effect lasted longer, indicating that gemfapixin has broad prospects for clinical application.

Regarding the safety of the drug, although the common side effect of Gemfapixen is abnormal taste, this adverse reaction is usually mild and can be tolerated by most patients. Unlike traditional opioids, Gemfapixin does not cause addiction or central nervous system depressant effects, so its advantages as a non-narcotic antitussive drug are very prominent. Although dysgeusia is common in some patients, the reversibility of this side effect makes Gemfapixin well tolerated.

Reference materials:https://www.ema.europa.eu/en/medicines/human/EPAR/lyfnua