The FDA has cleared Crown Point, Ind.-based OYE Therapeutics’ investigational new drug application for OYE-101, clearing the company to begin clinical development.
OYE-101 is an intravenous caffeine formulation being developed to reverse the effects of, or accelerate emergence from, general anesthesia and deep sedation in adults. The therapy is also under development as a respiratory stimulant for opioid-induced respiratory depression, according to a Feb. 2 news release.
The IND clearance supports a Phase 1 randomized, active- and placebo-controlled, single ascending dose study evaluating the safety, tolerability and pharmacokinetics of OYE-101 in healthy volunteers. The FDA milestone advances work OYE previously said would be supported by a $5 million convertible note financing round, oversubscribed to $5.6 million, to move its intravenous caffeine-based therapy into clinical trials.
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