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Global trials provide hope for sufferers of chronic cough

Friday March 4th 2022

A new drug can ease chronic cough with few side effects, researchers report today.

Gefapixant has the potential to have a significant impact on the lives of thousands of sufferers, said principal researcher Professor Jacky Smith, professor of respiratory medicine at The University of Manchester.

The study published in today’s edition of *The Lancet* shows the drug reduced cough frequency in two phase 3, randomised, double blind 52-week trials, named Cough 1 and Cough 2.

The trials recruited 2,044 participants from 156 sites in 17 countries who had been suffering from chronic cough – one that lasts for more than eight weeks – for an average of 11 years.

In the Cough 1 trial, 730 participants were given either gefapixant 45 mg, 15 mg or a placebo and in the Cough 2 trial, 1,314 participants in the were given either gefapixant 45 mg, 15 mg or a placebo.

The research team found that gefapixant 45 mg resulted in an 18.5% reduction in 24-hour cough frequency compared to placebo in Cough 1 and a 14·6% reduction in Cough 2.

Both studies demonstrated gefapixant 45 mg was effective on cough frequency reduction up to six months, while the 15 mg dose did not demonstrate a significant reduction in cough frequency compared to placebo.

Over the 52-week trial period, some patients in the gefapixant 45 mg group experienced to mild or moderate taste disturbances, which reversed while on the treatment or after discontinuation. More serious side effects were rare.

Prof Smith, who is also director of NIHR Manchester Clinical Research Facility (CRF), said: “These global trials have confirmed that this drug has exciting potential for patients who suffer from chronic cough, an often distressing condition.

“Effective treatments for cough are a significant unmet clinical need and no new therapies have been approved in over 50 years.

“Billions of pounds are spent annually on over-the-counter cough and cold medicines despite a lack of evidence to support their efficacy, concerns about the potential for abuse and risk of harm in overdose.”

The impact of gefapixant, which targets P2X3receptors in the nerves that control coughing, was monitored using a special cough monitoring system that was developed in Manchester to counts coughs.

The drug was initially developed as a pain killer, until the researchers discovered it had a significant impact on chronic cough.

Prof Smith added: “We can’t say this drug is a cure for chronic cough, but it can and often does reduce the frequency of coughing substantially.

“Now these phase 3 trials have been successful, we feel this is a major step towards this treatment becoming available for our patients with chronic cough.

“That could make a big difference to patients who often struggle with this condition which can make such a big impact on their lives.”

Efficacy and safety of gefapixant, a P2X3 Receptor Antagonist, in Chronic Cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, placebo-controlled phase 3 trials. *Lancet* 4 March 2022

Tags: Pharmaceuticals | Respiratory | UK News

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