REQUA ANTIFLATULENT STUDIES: ACTIVATED CHARCOAL SUPERIOR TO SIMETHICONE
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).
More from Archive
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.