Indivior

C4X Discovery Holdings plc is pleased to note the announcement that Altasciences has been selected by Indivior PLC to conduct “A Phase I, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of INDV-2000 Under Fasting and Fed Conditions in Healthy Volunteers”.

C4X Discovery Holdings plc is pleased to note Indivior PLC’s announcement that the National Institutes of Health has granted Indivior’s application entitled “Clinical Evaluation of C4X3256, a Non-Opioid, Highly-Selective Orexin-1 Receptor Antagonist for the Treatment of Opioid Use Disorder” pursuant to Funding Opportunity Announcement RFA-DA-19-002 dedicated to the development of medications to prevent and treat opioid use disorder and overdose.

The U.S. Food and Drug Administration (FDA) approved Indivior’s Perseris for schizophrenia.

July can be a notoriously slow period for FDA activity, and this year is no different. There are only five PDUFA dates scheduled for the month, and the first one was a supplemental approval for Merck’s Keytruda. The PDUFA date was July 3, but it was approved June 13. At this point in the month there are only four more approvals on the docket, here are the remaining approvals scheduled for July.

Shares of Dr. Reddy’s Laboratories Ltd. are surging this morning after the FDA approved its generic version of Suboxone (buprenorphine and naloxone) sublingual film for opioid addiction.

The FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18 to 1 to recommend Indivior’s RBP-6000 to treat opioid use disorder.