Professor researches anti-nausea drug
By HENRY GENS | Friday, September 20, 2013
By HENRY GENS
Chemotherapy can be a long and painful experience for a cancer patient, but a recently recognized series of clinical studies on an antiemetic may help doctors to mitigate some of the more disruptive side effects.
The studies, led by Notre Dame Adjunct Professor of Chemistry and Biochemistry Rudolph Navari, found that the use of olanzapine as an antiemetic was as adept as the current standard-of-care in preventing vomiting and far more effective in reducing nausea.
Navari’s research is part of a wider effort in the field of oncology to improve the recovery process for patients receiving chemotherapy.
“It’s been a goal of modern chemotherapy is to move from inpatient to outpatient treatment so that patients can return to daily life as soon as possible,” Navari said.
Antiemetic drugs are largely responsible for the progress in moving patients from hospital stays back to their normal routines.
“Twenty years ago most chemotherapy patients would be confined to the hospital, but in the last fifteen to twenty years we’ve made huge advances, although we still need to do better,” he said. “Only about one-half to two-thirds of outpatients have what we would characterize as ‘good outcomes’ with current antiemetic drugs.”
Navari’s recent contribution to the field is the clinical testing of one such drug, generically known as olanzapine. He said he first got the idea to try clinical trials involving the drug nearly a decade ago from a colleague.
“A friend of mine at the time was working with a population of patients needing antipsychotic drugs, and he noticed that one drug in particular, Zyprexa – the brand-name of olanzapine – had the unique side effect of greatly reducing nausea,” Navari said. “After he told me this I immediately thought of its potential as an antiemetic for chemotherapy patients.”
Over the next several years Navari led a team that conducted Phase I, II and III clinical trials on olanzapine’s effectiveness as an anti-nausea and anti-vomiting agent.
“In the first phase we were merely testing different dosages and combinations for efficacy and safety, finding out that the best dosage was around ten milligrams per day,” he said. “Then we moved on to the Phase II trials and found that it compared favorably to other antiemetic drug regimens, without worse side effects. Finally in the Phase III trials with a much larger number of patients we compared it to the standard of care and found that it was just as good in preventing vomiting, but much better in preventing nausea.”
These clinical studies were concluded roughly two years ago, according to Navari, but the research is still being disseminated and only recently published last year. Evidence of the study’s impact in the field of oncology was demonstrated over the summer when the National Comprehensive Cancer Network, a well-regarded non-profit alliance of nearly two-dozen leading cancer centers, endorsed olanzapine as the first-line antiemetic therapy.
In addition to olanzapine’s demonstrated effectiveness, its status as a generic drug provides an additional benefit for patients.
“The patent protection on the antipsychotic indication of olanzapine expired during the study, so now it’s available as a generic drug and hence is much more affordable for patients, amounting to only fifty cents a dose,” he said. “While getting FDA-approval for an antiemetic indication in chemotherapy would be prohibitively expensive, doctors are fortunately able to prescribe it for off-label use in this context.”
As a result of the comprehensive, evidence-based research performed by Navari, he said he hopes cancer patients undergoing chemotherapy will be able to come closer to achieving some semblance of normality in their daily lives.
“I would say that it is very satisfying to know that what I’ve done will help so many people,” he said.
Contact Henry Gens at [email protected]