New Drug For H Pylori : Talicia Gets US FDA Approval, But Thailand Medical News Warns That It Contains PPIs
, a new drug to treat Helicobacter pylori
) infections in adults that is manufactured by Israel-based RedHill Biopharma has secured the US Food and Drug Administration
bacteria infects more than 50% of the global population, including 35% in the US. Among the many digestive problems that it causes, it also leads to ulcers and in certain cases gastric cancer.
Typically, H pylori
infections are treated by antibiotics such as clarithromycin. However of late the infections are becoming drug resistant. According to estimates, the resistance of H pylori
to clarithromycin nearly doubled during 2009-2013.
According to Thailand Medical
News, Talicia is a combination of antibiotics, amoxicillin and rifabutin, along with proton pump inhibitor
Talicia is intended to address the growing resistance of the bacteria to the commonly used antibiotics in current standard-of-care therapies such as clarithromycin-based treatments.
approval supports positive results from two Phase III studies enrolling H pylori
-positive adults with epigastric pain or discomfort in the US. Data from the Phase III confirmatory study revealed 84% eradication of H pylori
infection when treated with RedHill’s drug versus 58% in the active comparator arm.
In participants with measurable blood levels of drug at day 13, response rates were 90.3% and 64.7% with Talicia and the active comparator, respectively.
Trial data did not show any resistance to rifabutin, a principal component of the drug. Furthermore, 1% of subjects on RedHill’s drug had adverse reaction-related treatment discontinuation.
RedHill Biopharma CEO Dror Ben-Asher said: “The FDA
’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases. We are working to expand our sales force to approximately 140 representatives who will promote Talicia, Aemcolo and other gastrointestinal-focused products in our basket.”
RedHill expects to launch Talicia in the US in the first quarter of next year. The company noted that the drug’s Qualified Infectious Disease Product (QIDP) designation provides market exclusivity in the country for eight years.
News points out however that the clinical trials did not point out how long a duration on the new drug was needed to clear H pylori
infections and whether the PPI
content in the drug ie omeprazole
could create a situation that dependence on PPIs
would result or a situation in which the post effect of the drug would create a situation where treatments on PPIs
would be needed.
News states that it is clearly very irresponsible of the US FDA
to clear new drug combos that contains PPIs
considering the fact that there has been so many new emerging medical studies that link PPIs
with a variety of complication and health issues including kidney diseases and kidney failure, cardiovascular incidences, cholangitis
and a host of other medical issues.
The US FDA
has also failed to issued package warnings on PPIs
and also combo drugs or drug preparations containing PPIs.
For more details about the negative issues associated with PPIs
, look at the following past articles: