Anavex Life Sciences Corp (AVXL)

[Doc328]

It's quite a bit more complex. Most insomnia drugs have been approved with a couple P3 trials with 300-900+ patients each. At least one of the phase 3 trials will need objective findings from polysomnography (PSG) as a primary endpoint (overnight sleep study in sleep lab) to determine objective sleep onset latency, WASO, total sleep time, sleep efficiency, etc. The other P3 can have a primary endpoint that is subjective with sleep diary.

Anavex has some sleep data that does not rise to this standard for approval for an insomnia treatment. The AD 2a data was based on 3 questions about early, mid and late night insomnia/awakenings scored 0-2 from the 21 question HAM-D depression scale. The PDD study had a subjective sleep scale (SDS-CL-25) and apparently had actigraphy (results were not reported) but there was no PSG. Anavex reported an improvement in REM sleep disorder symptoms (some PDD patients have this) presumably corresponding to responses to question 21-23 on the SDS-CL25. The AD phase 2b had the RSCAQ (Retrospective Sleep Continuity Assessment Questionnaire) scale.

When Anavex begins the AD P3 they could add an objective endpoint, but baseline and treatment PSG would be expensive. Additionally, additional exclusion criteria for insomnia would slow recruitment.



Link to SDS-CL scale https://www.med.upenn.edu/cbti/assets/user-content/documents/SDS-CL-25mp-kk-cj1-22-16V1.pdf
I could not find a link to the RSCAQ