Pfizer drug JUVANTA passes UK first stage

Image copyright Getty Images Image caption The Active Juvastatin (JUVANTA) pump remains a popular treatment in the US Pfizer’s lead opioid blocker has passed its first trial in the UK, a UK regulatory news…

Pfizer drug JUVANTA passes UK first stage

Image copyright Getty Images Image caption The Active Juvastatin (JUVANTA) pump remains a popular treatment in the US

Pfizer’s lead opioid blocker has passed its first trial in the UK, a UK regulatory news bulletin said.

Injectable version of the drug JUVANTA was given to half of patients suffering from long-term bowel problems, known as Omicron.

It can lead to chronic relief of bowel pain for severe cancer patients.

But doctors have warned that the drug is less effective in post-chemotherapy pain.

A phase 3 clinical trial revealed that the oral version was not any more effective in relieving pain in post-chemotherapy patients, and that doses given daily for more than three weeks did not demonstrate “major drug-related adverse events”.

In addition, the FDA and the European Medicines Agency (EMA) have not yet approved JUVANTA. It is not currently licensed to treat post-chemotherapy pain.

Improving opioid therapy

Patients in the phase 3 trial had been undergoing chemotherapy, in which these treatment-resistant conditions – known as resistant tumours – are formed.

Over the duration of the trial, JUVANTA boosted pain relief in those patients, from 30% to 87% in 10 months.

The National Institute for Health and Care Excellence (Nice) and European Medicines Agency (EMA) are considering the drug’s use to improve opioid therapy.

There is also a phase 3 trial underway to help assess the effectiveness of JUVANTA against chronic post-chemotherapy pain.

A summary of the phase 3 clinical trial said that similar to data from another phase 3 trial, the device used in the phase 3 study was not more effective in alleviating pain in the chronic disease.

More trials to be done

Of those studied, 24 patients were given the oral JUVANTA versus a placebo and 23 patients were given a different medication, tamoxifen.

Although the study was small – just 78 patients – it used a different treatment route to studies involving the injection of JUVANTA.

Previous studies on the treatment also failed to meet its initial goal, suggesting that additional trials will be needed before JUVANTA is licensed for treatment of post-chemotherapy pain.

Dr Sarah Brown of AstraZeneca, the company developing the drug, said JUVANTA was now the only permanent drug to treat resistant tumours in the UK.

“This study adds to our growing knowledge about the power of long-term medication as a way to reduce pain and improve quality of life for patients with refractory bowel cancer,” she said.

At 14:58 BST, a Pfizer spokesperson had provided the following comment:

“Earlier this year, Pfizer and AstraZeneca announced positive results from a phase three study of JUVANTA(also known as infliximab) in patients with moderately to severely refractory GI to non-operative polycythemia vera or disseminated tumours.

“The phase three treatment trial sought to compare and contrast treatment with the systemic flurbiprofen hydrochloride (flurofen hydrochloride) administration of the [mild-to-severe polycythemia vera treatment] therapy, compared to the sustained persistent, intramuscular injection of the infusions of JUVANTA in two groups of patients and an independent monitoring board.

“Similar results were achieved in the primary and secondary endpoints. This is an important milestone in the development of the products and will enable the companies to discuss the future potential for the product.”

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