Please tell us about your clinical experience. How many patients do you currently treat with FSD?

What can you tell us about the melancortin receptor agonist (MCR4) mechanism of action?

The Change in Desire Score was more than double in Vyleesi 1.75mg compared to placebo, from ~0.2 to ~0.5. What is your interpretation of this data?

Out of the 2500 patients in the trials who had the option, after completion, to continue in an open-label safety extension study for an additional 12 months, ~80% elected to remain and receive Vyleesi. How encouraging is this fact? Does it vouch for its efficacy?

What % of your FSD patients do you think would try Vyleesi?

Based on your experience in this space, how would the market need in FSD compare to that in male ED? What % of the FSD market is untapped?

Addyi has not done well since approval. What do you think are the major reasons for this? 

• Lack of efficacy
  
• Lack of market need
• Inability to consume alcohol while on the drug
• Daily dosing requirement
• Other?

Much has been made in the media about the efficacy of Vyleesi being minimal. Can you comment on the scale used in the trials and clinical relevance of the results?

How limiting/concerning is the hyperpigmentation reported in the label:

5.2
In the phase 3 placebo-controlled trials, focal hyperpigmentation, including involvement of the face, gingiva, and breasts, was reported in 1% of patients who received up to 8 doses per month of VYLEESI compared to no placebo-treated patients. In another clinical study, 38% of patients developed focal hyperpigmentation after receiving VYLEESI daily for 8 days; among patients who continued VYLEESI for 8 more consecutive days, an additional 14% developed new focal pigmentary changes. Patients with dark skin were more likely to develop focal hyperpigmentation. Resolution of the focal hyperpigmentation was not confirmed in all patients after discontinuation of VYLEESI.

How limiting/concerning is the nausea rate reported in the label:
5.3
In the phase 3 placebo-controlled trials, nausea was the most commonly reported adverse reaction, reported in 40% of VYLEESI-treated patients, requiring anti-emetic therapy in 13% of VYLEESI-treated patients and leading to premature discontinuation from the trials for 8% of VYLEESI-treated patients. Nausea improves for most patients with the second dose

Can you comment broadly on the efficacy shown in the label? The scales used are only 1-6 points or 0-4, so can you help us understand the benefit of change seen? 

• For example a .6 improvement vs. .2 seems very small.  On a % change from baseline it is a 24% improvement vs. 10%. What's the right away to understand think about the magnitude of benefit?

Is the goal in treating patients with HSDD to help them achieve sexually satisfying events?

• If not, what is the goal? Do the other questionnaires better capture the treatment objective?
• If it is, does Table 4 in the label make the drug less/not useful in treating patients?
  • Key takeaway from Table 4: "There was no significant difference between treatment groups in the change from baseline to end of study visit in the number of satisfying sexual events (SSEs), a secondary endpoint."