Amag got an unexpected US thumbs up for its female hypoactive sexual desire disorder (HSDD) project Vyleesi on Friday. But the bigger question is whether there will be a market for the drug, or if it will go the same way as Sprout Pharmaceuticals’ Addyi, which reportedly sold just $13m at its 2016 peak. Apart from the questionable efficacy of Vyleesi – the FDA noted no difference between the drug and placebo in the number of satisfying sexual events in phase III – side effects might hold back sales. Patients are meant to inject Vyleesi at least 45 minutes before having sex, but their plans could be scuppered by nausea, which was reported in 40% of subjects, often within an hour of dosing. At least Vyleesi can be taken alongside alcohol, unlike Addyi. Still, the main question is whether female HSDD is even a disease. Leerink analysts estimated that around six million premenopausal women are affected, but admitted that 95% do not know that they have a medical condition. This did not stop them saying Vyleesi could make $90m by 2025. Amag’s stock climbed 18% in premarket trading this morning while Vyleesi's originator, Palatin, was up 50%; however both stocks were in the red later today.
|Vyleesi vs Addyi|
|Product||Company||Mechanism||Delivery||Warnings||2024e sales ($m)|
|Addyi||Sprout Pharmaceuticals||5-HT1A agonist & 5-HT2A antagonist||Oral, once daily||Severe hypotension and syncope risk with alcohol & CYP3A4 inhibitors (black box warning); only available through REMS programme||-|
|Vyleesi||Amag/Palatin||Melanocortin 4 agonist||Subcutaneous injection, as needed||Transient hypertension, focal hyperpigmentation, nausea||151|
|Source: EvaluatePharma, product labels.|