Which format?
| Nasal spray | Vial | |
|---|---|---|
| Concentration | 1 mg per mL (10 mg in 10 mL); each 0.1 mL of solution contains 100 micrograms | — |
| How supplied | Ready-made solution in a 10 mL spray bottle | — |
| Needs mixing? | No. The lyophilised 10 mg vial needs reconstitution; the spray does not | Yes, with BAC water |
| Storage | 2–8 °C, upright, away from light; do not freeze | −20 °C dry; 2–8 °C mixed |
Storage and handling
Keep the spray solution in a refrigerator at 2–8 °C, capped and away from light. A peptide in solution breaks down faster than dry powder, so for long storage the lyophilised vial kept at −20 °C is the more stable choice.
Studies that used the intranasal route
| Study | Model | Dose used | Duration | Finding |
|---|---|---|---|---|
| Safarinejad MR et al.2008 · J Urol · PMID 18206919 | Human, randomised double-blind placebo-controlled trial (n=342 men with erectile dysfunction not responding to sildenafil) | 10 mg intranasal, 45 minutes to 2 hours before sexual stimulation | At least 16 attempts at home | Positive clinical results were reported in 33.5% on bremelanotide versus 8.5% on placebo (p=0.03), with greater intercourse satisfaction. Drug-related adverse effects were more frequent with bremelanotide (p=0.01). |
| Diamond LE et al.2005 · Urology · PMID 15833522 | Human, randomised crossover trial (n=19 men with erectile dysfunction) | 7.5 mg intranasal PT-141 with 25 mg sildenafil | Single doses; 6-hour post-dose assessment | The combination produced a significantly greater erectile response than sildenafil alone. It was well tolerated, with no new or more frequent adverse events. |
| Diamond LE et al.2006 · J Sex Med · PMID 16839319 | Human, randomised double-blind crossover trial (n=18 premenopausal women with sexual arousal disorder) | 20 mg intranasal, single dose | Single session, 24-hour follow-up | More women reported moderate or high desire after bremelanotide than after placebo (P=0.0114), and more of those who attempted intercourse were satisfied with their arousal (P=0.0256). Vaginal vasocongestion did not change significantly. |
The approved bremelanotide product is a subcutaneous injection, and the phase 3 RECONNECT trials used 1.75 mg subcutaneously. The intranasal studies below are earlier, smaller trials from 2005–2008. They used doses of 7.5 to 20 mg, much larger than the subcutaneous doses.
Nasal spray FAQ
Is there research on PT-141 nasal spray?
Yes, three trials in our records used intranasal bremelanotide. They tested 10 mg in 342 men who did not respond to sildenafil, 7.5 mg with sildenafil in 19 men, and a single 20 mg dose in 18 women with arousal disorder. All three date from 2005 to 2008.
Is the approved form of PT-141 a nasal spray?
No. The approved bremelanotide product, Vyleesi in the USA, is a subcutaneous injection, and the phase 3 trials used 1.75 mg subcutaneously. Nasal spray was tested in earlier trials but is not an approved form.
What is the concentration of the PT-141 nasal spray?
The spray holds 10 mg of PT-141 in 10 mL of solution, which is 1 mg per mL. Each 0.1 mL therefore contains 100 micrograms. This is the concentration of the solution, not a dose.
Nasal spray or vial: which suits a lab better?
The vial suits work that needs a chosen concentration or long storage, because the dry powder keeps best at −20 °C and is made up only when needed. The spray is already in solution at 1 mg per mL, so there is no reconstitution, but it has to be refrigerated and has a shorter shelf life.
The full PT-141 rundown
Research, vial sizes, storage and FAQs are on the main PT-141 page.
View PT-141 →