Narcan Receives FDA Approval for Nonprescription Sale

On March 29, 2023, the U.S. Food and Drug Administration (FDA) approved Emergent BioSolutions to sell Narcan^® (naloxone) 4mg/0.1mL nasal spray over-the-counter(OTC). Used to reverse the effects of an overdose with opioid drugs, Narcan soon will be available to buy online as well as at convenience stores, gas stations, and other easily accessible locations. However, implementation of labeling changes and administrative procedures may take several months before the switch is finalized and the OTC product becomes widely distributed. It is used in emergency situations to resuscitate patients who are in respiratory failure after an acute opioid overdose. By blocking opioid receptors, it displaces the opioid drug and decreases the negative effects of a drug overdose. Its directions are to administer one dose (one spray) as soon as an overdose is observed or suspected. Emergency medical help should be requested immediately after giving the drug. If needed, one additional dose (in alternating nostrils) can be given every two to three minutes until professional assistance arrives. Few side effects are associated with the use of Narcan, but some patients may experience temporary constipation, headache, and/or nausea. It is not effective for overdoses of non-opioids, such as methamphetamine; but it is not harmful if administered accidentally to a person who has not overdosed – someone who is unconscious as a result of very low blood sugar, for example. Harm Reduction Therapeutics, a non-profit organization, also has requested OTC status for its 3mg/0.1mL nasal spray naloxone, RiVive^™. The FDA is expected to rule on this application on or before April 28, 2023. Higher strengths and other dosage forms of naloxone will remain prescription only. Pricing information for OTC Narcan is not yet known. 

Indication Extended for Vuity

AbbVie was granted approval by the FDA on March 28, 2023, to expand the use of Vuity^® (pilocarpine ophthalmic solution) by 1.25%. Originally approved in November 2021, it treats presbyopia, which makes objects close to the eyes look fuzzy. Vuity’s patented formulation affects the composition of the tears that bathe the eyes to help reduce the size of the pupils and reduce blurriness. It begins to work in about 15 minutes and close vision remains clear for up to six hours. The initial recommended dose was one drop in each eye once a day. Now, the FDA has approved adding a second drop, if needed, between three and six hours after the first drop. Look here for revised prescribing information.

Full Approval for Keytruda to Treat Some Solid Tumors

Keytruda^® (pembrolizumab – Merck) now is fully approved for treating patients who have advanced solid tumors that test positive as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). The FDA converted an earlier Accelerated Approval for the indication to regular approval on March 28, 2023. Candidates for its use have exhausted available treatments for appropriate inoperable or metastatic cancers that have worsened despite previous drug therapy. MSI-H and dMMR, estimated to affect about 15% of solid tumors, are associated most often with cancers of the colon/rectum, endometrium, and gastrointestinal (GI) tract, but they can occur in other body tissues, as well. To treat them, Keytruda is administered by intravenous (IV) infusion for up to two years, until cancer begins to progress or until the patient can no longer stand the drug’s side effects. The recommended dose for children is 2mg/kg of body weight (up to 200mg) once every three weeks; for adults, the dose is 200mg once every three weeks or 400mg once every six weeks. Updated prescribing information is here.

Additional Newsflash Sent This Week

• Joenja Approved for Activated Phosphoinositide 3-Kinase Delta Syndrome – Monday, March 27

Long COVID Issues Document Available

The Emerging Therapeutics department has prepared an issues document about Long COVID. It includes information on the condition, its symptoms, its possible causes, and its ongoing impact on healthcare.