Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

REQUA ANTIFLATULENT STUDIES: ACTIVATED CHARCOAL SUPERIOR TO SIMETHICONE, currently the only product with Category I status under FDA's Final Monograph for OTC antiflatulent products. In a study of breath hydrogen levels, 10 patients were randomly tested with a noncarbohydrate placebo, activated charcoal (260 mg per capsule), and simethicone (20 mg per capsule). Compared to placebo, "activated charcoal reduced peak breath H[2] levels," Requa reported, while simethicone "did not result in significant reduction in breath H[2] levels." Moreover, "data clearly indicate that activated charcoal is an effective anti-gas medication," Requa stated. "Simethicone, also commonly prescribed for gaseousness, was not found to be effective." The simethicone comparison study is one of three randomized, double-blind, placebo-controlled studies submitted by Requa to FDA on Oct. 27. Requa is seeking Category I(END ITALICS) status for Charco-caps activated charcoal capsules. According to Requa, the recently submitted studies "have shown activated charcoal to be effective, to a statistically significant degree, in reducing breath hydrogen, and by extrapolation, intestinal gas." For approved labeling, Requa proposed: "To alleviate or relieve the symptoms of gas. . . . Take 2-4 capsules 30 minutes before and after meals or at the first signs of discomfort or as directed by your physician. Repeat 1/2 to one hour as needed up to 10 gm/per day, not to exceed 7 days." The company noted that FDA might revoke the Antiflatulent Final Monograph and reclassify all antiflatulents as digestive aids under a proposed Digestive Aid Drug Products Monograph. In that case, Requa asked that FDA "reopen the administrative record for the Proposed Digestive Aid Drug Products Monograph to recategorize activated charcoal as a Caegory I digestive aid ingredient for the treatment of intestinal distress." Last summer, Requa submitted a 51-patient study in support of an OTC antidiarrhea claim. In that study 58% of patients receiving the activated charcoal product experienced "very good" relief of symptoms, compared to 38% of placebo patients, Requa reported. The company also submitted a petition requesting FDA to reopen the administrative record for the Antidiarrheal Tentative Final Monograph to reclassify activated charcoal from Category III to Category I prior to publication of the final monograph ("The Pink Sheet" July 6, T&G-3).

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts