Medication for nausea and vomiting from chemotherapy approved by US FDA

14 Oct 2014

Nausea and vomiting are common side effects of chemotherapy. The US FDA has approved a treatment (netupitant and palonosetron, trade name: Akynzeo), taken as a capsule, against these conditions. The treatment consists of two components, which act in two phases.

Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.

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"Supportive care products, such as Akynzeo, help ease the nausea and vomiting patients may experience as a side effect of cancer chemotherapy," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research.

Two trials helped establish the treatment's effectiveness

Akynzeo's effectiveness was established in two clinical trials of 1,720 participants receiving cancer chemotherapy. Participants were randomly assigned to receive Akynzeo or oral palonosetron. The trials were designed to measure whether the study drugs prevented any vomiting episodes in the acute, delayed and overall phases after the start of cancer chemotherapy.

Results of the first trial showed that most patients did not experience any vomiting or require rescue medication for nausea, in specific phases of the chemotherapy course:

  • 98.5% did not experience episodes during the acute phase
  • 90.4% did not experience episodes during the delayed phase
  • 89.6% did not experience episodes during the overall phase.

In contrast, participants treated with oral palonosetron did not experience any vomiting or require rescue medication for nausea as follows:

  • 89.7%% did not experience episodes during the acute phase
  • 80.1%% did not experience episodes during the delayed phase
  • 76.5%% did not experience episodes during the overall phase.

The second trial showed similar results.

Side effects caused by the treatment during trial

Common side effects of Akynzeo in the clinical trials were headache, weakness (asthenia), fatigue, indigestion (dyspepsia) and constipation.

 

Source: Medical News Today
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