GlaxoSmithKline announces acceptance of post operative ileus drug

GlaxoSmithKline has revealed that Entereg, its drug for post-operative ileus developed with Adolor, has had its approvable letter accepted by the FDA – a “complete” response to the drug’s review.

Post-operative ileus (POI) is a bowel condition sometimes occurring after abdominal surgery characterised by abdominal pain, nausea, vomiting, distension, reduced appetite and inability to pass solids or gases. POI can be exacerbated by the use of opioid painkillers. It is responsible for a “substantial burden” on hospital resources, according to Glaxo, because the ailment prolongs hospital stays.

Glaxo says there are no drugs available for the treatment POI and that few advances have been made in the past 100 years for the treatment of the condition.

Kevin Lokay, vice-president of oncology and acute care at Glaxo, said: “We were delighted to announce positive results of Study 314 in February of this year, setting the stage for this complete response to the Agency.”

“This is an important step toward our goal of bringing a new treatment option to physicians who treat POI and to patients who may benefit. We will be working closely with Adolor in the regulatory review process,” he added.

Entereg has been produced in a worldwide development and commercialisation collaboration between Glaxo and Adolor, which is a biopharmaceutical company specialising in the development and discovery of novel prescription drugs for pain relief.

Yesterday it was reported in the Financial Times that Glaxo are set to bid $15 billion for Pfizer’s consumer healthcare arm, which produces the decongestant Sudafed and Listerine mouthwash. Glaxo already produces Aquafresh toothpaste and Panadol, the UK’s most popular paracetamol product.

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