Benzocaine Monograph For Toothache Requires Further Study – FDA
This article was originally published in The Tan Sheet
Executive Summary
FDA says benzocaine-containing oral analgesic manufacturers will have to conduct a larger clinical trial to support a Category I (safe and effective) classification for the treatment of toothaches
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Benzocaine study
The Consumer Healthcare Products Association should implement a series of controls in its upcoming study to rate the efficacy of 10% and 20% benzocaine in relieving toothache pain, FDA states in a Feb. 28 letter. The agency responds to CHPA's call for revised protocol on the group's three-arm, placebo-controlled, toothache dose-response trial submitted in December (1"The Tan Sheet" Jan. 17, 2005, p. 11). FDA's recommendations include use of a visual analog scale score, in addition to the Dental Pain Scale, for pain assessment. The agency also suggests that "assessment of onset, duration and magnitude of pain relief be compared to the outcome of a global satisfaction assessment" in order to demonstrate clinically significant differences in treatments. CHPA should include "instructions for uniform selection and dosing of rescue medications" in the protocol for both pediatric and adult subjects. The study is being conducted in response to FDA's 2004 request for a larger clinical trial to study benzocaine for toothaches (2"The Tan Sheet" July 5, 2004, p. 9)...
Benzocaine study
The Consumer Healthcare Products Association should implement a series of controls in its upcoming study to rate the efficacy of 10% and 20% benzocaine in relieving toothache pain, FDA states in a Feb. 28 letter. The agency responds to CHPA's call for revised protocol on the group's three-arm, placebo-controlled, toothache dose-response trial submitted in December (1"The Tan Sheet" Jan. 17, 2005, p. 11). FDA's recommendations include use of a visual analog scale score, in addition to the Dental Pain Scale, for pain assessment. The agency also suggests that "assessment of onset, duration and magnitude of pain relief be compared to the outcome of a global satisfaction assessment" in order to demonstrate clinically significant differences in treatments. CHPA should include "instructions for uniform selection and dosing of rescue medications" in the protocol for both pediatric and adult subjects. The study is being conducted in response to FDA's 2004 request for a larger clinical trial to study benzocaine for toothaches (2"The Tan Sheet" July 5, 2004, p. 9)...
Benzocaine study
The Consumer Healthcare Products Association should implement a series of controls in its upcoming study to rate the efficacy of 10% and 20% benzocaine in relieving toothache pain, FDA states in a Feb. 28 letter. The agency responds to CHPA's call for revised protocol on the group's three-arm, placebo-controlled, toothache dose-response trial submitted in December (1"The Tan Sheet" Jan. 17, 2005, p. 11). FDA's recommendations include use of a visual analog scale score, in addition to the Dental Pain Scale, for pain assessment. The agency also suggests that "assessment of onset, duration and magnitude of pain relief be compared to the outcome of a global satisfaction assessment" in order to demonstrate clinically significant differences in treatments. CHPA should include "instructions for uniform selection and dosing of rescue medications" in the protocol for both pediatric and adult subjects. The study is being conducted in response to FDA's 2004 request for a larger clinical trial to study benzocaine for toothaches (2"The Tan Sheet" July 5, 2004, p. 9)...