A drug is being developed that will selectively bind and reverse the effects of skeletal muscle relaxants. This new medication will not possess the unwanted muscarinic effects of neostigmine, which is currently used for that purpose. The drug appears to be effective. However, in a large study group/trial prior to the release of the drug on the market, it was discovered that this medication might produce allergic reactions at an unacceptably high rate. Release of the drug was held back by the FDA. At what phase of drug development was this possible allergic side effect discovered?
- Phase I.
- Phase II.
- Phase III.
- Phase IV.
- Phase V.
During Phase III trials, formal clinical trials in a large number of patients demonstrate the drug's efficacy compared with existing treatments and determine the incidence of unwanted effects. Non–life-threatening allergic symptoms such as rashes were detected in patients treated with Sugammadex during Phase III trials.
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