Oxytocin nasal spray

Is oxytocin nasal spray FDA-approved?

No nasal oxytocin product currently holds FDA approval. Oxytocin itself is approved only as an injection: Pitocin's label describes it as "a sterile, clear, colorless aqueous solution of synthetic oxytocin," a "nonapeptide found in pituitary extracts from mammals," indicated to initiate or improve uterine contractions toward vaginal delivery, and also used postpartum [1]. A nasal formulation, Syntocinon (40 USP units/mL), previously held FDA approval under NDA 012285, but its listed marketing status is now "Discontinued" [2].

What have large clinical trials found?

The largest randomized trial tested intranasal oxytocin in 290 children and adolescents with autism spectrum disorder, ages 3 to 17, over 24 weeks at a target dose of 48 IU daily; it "showed no significant between-group differences" from placebo on measures of social or cognitive functioning, and adverse-event rates were similar between groups [3].

Can oxytocin nasal spray be compounded?

Oxytocin is an ingredient in an FDA-approved drug, Pitocin [1]. Separately, section 503A lets a pharmacy compound only from a bulk substance that has a USP or NF monograph, is a component of an FDA-approved drug, or is on FDA's 503A bulks list [4]. Neither fact by itself establishes that a specific compounded nasal oxytocin product meets every condition FDA sets.