PT-141 nasal spray is not a new idea. Bremelanotide began its life as a spray, and most of the early human studies used one. The route was abandoned before approval, and the reasons bear directly on anyone considering a spray today.
The approved product and its trials are covered in the PT-141 approval and trials, and the approved dose in PT-141 dosage. This page is about the nasal studies. The broader options are on the sexual health goal page.
The nasal studies
The first published human studies gave bremelanotide as a single nasal spray. They enrolled healthy men and men with mild to moderate erectile dysfunction who responded to Viagra [1]. Blood levels rose with the dose, peaked at a median of 0.5 hours and had a half-life of about 1.9 to 2.1 hours. Erections were significantly better than on placebo only at doses above 7 mg.
A crossover study in 19 men with erectile dysfunction paired 7.5 mg by spray with 25 mg of sildenafil [2]. The combination produced a stronger erectile response than sildenafil alone, with no new side effects.
In women, 18 premenopausal women with sexual arousal disorder took a single 20 mg spray or placebo in the clinic [3]. More reported moderate or high desire after the drug. Blood flow measured in the vagina during an erotic video did not change.
| Study | Route and dose | Who |
|---|---|---|
| Early safety and erection study | Nasal, single doses; effect above 7 mg | Healthy men and men with ED |
| With sildenafil | Nasal 7.5 mg plus sildenafil 25 mg | 19 men with ED |
| Arousal disorder pilot | Nasal 20 mg, single dose | 18 premenopausal women |
| Alcohol interaction study | Nasal 20 mg on 3 days | 12 men and 12 women, healthy |
| Vyleesi label | Injection 1.75 mg | Premenopausal women with HSDD |
Why the spray was dropped
The developer explained the decision in its 2009 annual report [5]. It stated that blood pressure rose in some patients using the nasal form, and that this was a significant factor in stopping work on it as a first-line treatment.
The company linked the problem to absorption. It wrote that the blood pressure rises, and the rates of nausea and vomiting, were due at least partly to variable uptake through the nose. It added that plasma levels varied significantly between patients. The same report described a phase 1 trial of the injected form that found no significant difference in mean blood pressure from placebo.
How a 20 mg spray compared with the injection
The Vyleesi label still carries data from the nasal form. It describes a study of a single 20 mg nasal dose taken with alcohol [4]. It states that this dose reaches a peak blood level about 2.5 times that of the approved injection.
The published version of that study enrolled 12 men and 12 women, who took the 20 mg spray on 3 days with or without alcohol [6]. It found no significant interaction with alcohol and no significant drops in blood pressure on standing. It was a safety study in healthy people, not a test of whether the spray works.
The label’s own figures show why exposure is the issue. Injected bremelanotide reaches the blood almost completely, and its overdose section states that nausea, skin darkening and larger blood pressure rises are more likely at higher doses [4].
Where a nasal product stands now
Vyleesi, first approved in 2019, is the only FDA-approved bremelanotide, and it is an injection [4]. Its label gives no nasal dose. Bremelanotide does not appear in any of the three categories of the FDA’s list of bulk substances nominated for compounding, updated May 14, 2026 [7].
A nasal product sold today is not the product the approval covers, and no study has measured how much of it reaches the blood. For how a different compound fares as a spray, see NAD nasal spray. The injected form’s side effects are on bremelanotide side effects.