Akum Pharmaceutical gets CDSCO Nod to study GERD.FDC drug
New Delhi: Drug major, Akum Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct Phase III clinical trial of fixed-dose combination Pantoprazole Sodium IP eq To Pantoprazole 40mg plus Acotiamide Hydrochloride trihydrate IP (ER) IH 300mg capsules for the treatment of Gastroesophageal reflux disease (GERD).
However, the nod is subjected to a condition that refractive GERD should clearly be defined in inclusion criteria as per National ISG (Indian Society of Gastroenterology) guidelines on GERD.
This came in line the proposal presented by the firm along with revised Phase III Clinical trial protocol and bioequivalence study results before the committee.
Gastroesophageal reflux disease is defined as reflux of gastric content into the esophagus, resulting in significant symptoms and/or complications. Gastroesophageal reflux disease (GERD) is a digestive disease in which stomach acid or bile irritates the food pipe lining. This is a chronic disease that occurs when stomach acid or bile flows into the food pipe and irritates the lining. Acid reflux and heartburn more than twice a week may indicate GERD. Symptoms include burning pain in the chest that usually occurs after eating and worsens when lying down.
Pantoprazole is a proton pump inhibitor used to treat erosive esophagitis, gastric acid hypersecretion, and to promote healing of tissue damage caused by gastric acid. Pantoprazole is a first-generation proton pump inhibitor (PPI) used for the management of gastroesophageal reflux disease (GERD), for gastric protection to prevent recurrence of stomach ulcers or gastric damage from chronic use of NSAIDs, and for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome.
It can also be found in quadruple regimens for the treatment of H. pylori infections along with other antibiotics including amoxicillin, clarithromycin, and metronidazole, for example. Its efficacy is considered similar to other medications within the PPI class including omeprazole, esomeprazole, lansoprazole, dexlansoprazole, and rabeprazole.
Proton pump inhibitors such as pantoprazole are substituted benzimidazole derivatives, weak bases, which accumulate in the acidic space of the parietal cell before being converted in the canaliculi (small canal) of the gastric parietal cell, an acidic environment, to active sulfenamide derivatives. This active form then makes disulfide bonds with important cysteines on the gastric acid pump, inhibiting its function. Specifically, pantoprazole binds to the sulfhydryl group of H+, K+-ATPase, which is an enzyme implicated in accelerating the final step in the acid secretion pathway. The enzyme is inactivated, inhibiting gastric acid secretion.The inhibition of gastric acid secretion is stronger with proton pump inhibitors such as pantoprazole and lasts longer than with the H(2) antagonists.
Acotiamide Hydrochloride trihydrate belongs to a class of drugs called 'gastroprokinetics'. It is primarily used in the treatment of functional dyspepsia (indigestion). Functional dyspepsia (FD) arises when your upper digestive tract demonstrates symptoms of pain, upset, or early or extended fullness for a month or longer.
Acotiamide Hydrochloride trihydrate is a new gastroprokinetics (enhance the movement of food from the mouth through stomach and intestines) used for treating gastrointestinal symptoms such as heartburn, vomiting, nausea. It helps relieve the symptoms like bloating after a meal, pain/discomfort in the upper abdomen, and early satiety (feeling full after eating only a little food).
Acotiamide Hydrochloride trihydrate works by increasing the level of a chemical (acetylcholine) concentration, which increases the gastrointestinal peristalsis movement. Therefore, it increases the intestine motility, accelerates gastric emptying time, and improves food movement throughout the gastrointestinal tract.
At the recent SEC meeting for Gastroenterology and Hepatology, the expert panel reviewed the proposal and the protocol of the revised Phase III Clinical Trail and the BE study results of fixed-dose combination Pantoprazole Sodium IP eq to Pantoprazole 40mg plus Acotiamide Hydrochloride trihydrate IP (ER) IH 300mg capsules in detail.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed Phase III clinical trial with condition that refractive GERD should clearly be defined in inclusion criteria as per National ISG guidelines on GERD. The results of the study should be presented before the committee.
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