Amneal Receives FDA Approval For Nizatidine Oral Solution, The First Generic Oral Solution For Axid R In The Market
Amneal Pharmaceuticals is pleased to announce that it has received U.S. FDA approval to manufacture Nizatidine Oral Solution in the 15 mg/mL strength effective November 18, 2009. It is an AA-rated, therapeutically equivalent alternative to Axid ® Oral Solution (a licensed trademark of Braintree Labs). Nizatidine Oral Solution is the first available generic in oral solution form and marks Amneal's fourth liquid approval. It represents the company's first exclusive generic - Amneal has 180-day exclusivity to market the product beginning from the date of first shipment. Amneal will sell Nizatidine Oral Solution, a clear yellow, peppermint-flavored syrup, in a 16 fl oz/473 mL lightweight, UV-protected plastic bottle. Amneal's generic product does not require refrigeration. Nizatidine Oral Solution is an anti-acid indicated in the treatment and prevention of ulcers, the treatment of heartburn and the stomach disorder GERD (gastroesophageal reflux disease) as well as conditions associated with excess acid secretion.
Addex Pharmaceuticals (SWISS: ADXN) announced that based on preliminary review of the unblinded data from study 206, it has terminated development of ADX10059 for chronic indications, including long term treatment of gastroesophageal reflux disease and migraine prophylaxis. In study 206 the incidence of alanine transaminase (ALT) levels greater than five times the upper limit of normal ( > 5xULN) levels was 6% (16 of 257 patients); however, bilirubin remained normal in all but one patient. The elevation of ALT occurred in all dose groups and appears to be related to the duration of dosing. The incidence was 3.9% (10 patients) in the 100 mg group; 0.8% (2 patients) in the 50 mg group; 1.6% (4 patients) in the 25 mg group. No abnormalities of liver function were observed in the placebo group.
Cancer of the gullet, or oesophagus, is one of the ten most common cancers in the Western world, and there have been recent alarming increases in the number of cases each year in the US and UK. There is no good treatment, and sufferers frequently face a short, painful battle which ends all too quickly in death. Many of the cancers diagnosed are in people with a long history of heartburn. Chronic heartburn leads to the lower parts of the gullet being bathed in a toxic acid solution, and the lining of the gullet defends itself against this by changing itself into something which looks a lot like the lining of the lower intestines. Although the damaged tissue, called Barrett's oesophagus, is not cancerous in itself, its presence warns doctors that the patient has taken the first step towards cancer, and triggers a rigorous programme of monitoring, coupled with therapy to prevent further damage.
Barrett's epithelium is recognized as a complication of erosive esophagitis and is the pre-malignant condition for adenocarcinoma of the esophagus. A research team from Yokohama City University School of Medicine hypothesized that some macroscopic features of Barrett's epithelium might be useful for identifying a subgroup with a high risk for the development of esophageal adenocarcinoma. Their study was published on January 28, 2010 in the World Journal of Gastroenterology. They enrolled 869 patients who underwent endoscopy during a health checkup at their hospital. Based on the Prague C & M Criteria, they originally classified cases of Barrett's epithelium into two types based on its shape, namely, flame-like and lotus-like Barrett's epithelium, and into two groups based on its length, its C extent < 2 cm, and â 2 cm.
Early tumor formation in Barrett's esophagus (BE) can be effectively and safely treated with radiofrequency ablation (RFA), in combination with prior endoscopic removal of visible lesions, according to a new study in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association (AGA) Institute. "Barrett's esophagus is the most important risk factor for the development of esophageal cancer, but there is no generally accepted management strategy for patients with early neoplasia in Barrett's esophagus, " said Jacques J.G. H. M. Bergman, MD, of the Academic Medical Center and lead author of the study. "Combining endoscopic resection with complete removal of residual Barrett cells with radiofrequency ablation may decrease the recurrence of lesion formation and could potentially limit the number of Barrett's esophagus cases that progress to esophageal cancer.