Seelos Therapeutics Inc (SEEL)

[kingme123]

eicoman repost= great info.
eicoman Member Level Monday, 09/16/13 12:37:42 PM
Re: None



Post # of 11452







Eicoman's Top 10 - Femprox

Why Femprox works and will be moving forward:

1. Recent Vitaros approval in a major western market, by the EMA in the EU, validates not only Vitaros but NexAct and Femprox , this is a crucial turning point.

2. Because Femprox is the same drug as Vitaros, although in different concentration, Femprox works by the same mechanism in women as in men, topical increased blood flow to the target area with no systemic effects.
Study: http://www.ncbi.nlm.nih.gov/pubmed/9138056

3. NexAct clearly makes the difference, as shown by Vivus.
Vivus ran clinical trials using a topical alprostadil product for FSAD , and the trials were unsuccessful in that they showed no improvement over placebo effect.
But Femprox has seven studies including:
• PH2 trial in the USA with 100 women which showed a positive trend towards higher doses
• PH3 trial in China with 400 women, the PH3 trial had better trial design, which showed for the higher 900-µg dose, significant and clinically relevant improvements in primary arousal success and secondary efficacy outcomes (FSFI) and Global Assessment Questionnaire (GAQ) and FSDS.

4. The new Femprox trials will have a room temp product and an improved trial design regarding endpoints and the SSE score.


5. Femprox Safety
Phase II Trial USA - “Adverse events were generally mild or moderate in intensity and mainly involved localized reactions in the genital area” http://www.ncbi.nlm.nih.gov/pubmed/14504005
Phase III Trial China- “No drug related serious adverse events were reported ,
Only 5 patients (1.2%) withdrawn from the Phase III study because of local adverse events”
http://www.ncbi.nlm.nih.gov/pubmed/18564348

6. Femprox has been expanded from FSAD to include sexual interest, FSAID, a larger market.


7. Limited Competition. There is no significant competition to Femprox right now or really for the foreseeable future, since current products in development are systemic and rely on manipulating hormones, neurotransmitters or brain chemistry, all of which can cause serious side effects. http://formularyjournal.modernmedicine.com

8. Filbenserin is a possible competitor in the area of sexual interest to Femprox. It is an anti-depressant type drug for women with no sexual interest. Femprox with it’s expanded description of FSAID, also covers sexual interest but also covers the very large patient population with desire but lack of arousal and lubrication. Filbenserin has a PDUFA date later this month and if approved it could give APRI a boost, since it will be the first drug approved in this space, showing willingness on FDA’s part.

Looking at Filbenserin, it looks like they may have a shot with new trial work having been done.
http://sproutpharma.com/wp-content/uploads/2013/06/pharmceutical-approvals-monthly.pdf
"The new filing package includes a newer pivotal trial in which the drug met two co-primary efficacy endpoints, whereas results had been mixed in other studies.”

9. FSD could now face a friendlier regulatory climate. As required by the reauthorization of the Prescription Drug User Fee Act, FDA is holding patient-focused meetings in diseases with high unmet need. Female sexual dysfunction made the first cut of conditions. A patient-focused meeting is slated for between 2013 and 2015

http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm
http://www.elsevierbi.com/publications/the-pink-sheet/75/16/fdas-patientfocused-meetings-round-one-selections-include-diseases-broad-and-rare

10. SEPT. 2013 – Femprox Product Plan revealed in Q4 2013 – it is obvious from the 9/11 conf call and corp presentation that APRI is already well under way with executing of plans for moving forward with Femprox

Key Femprox Initiatives
–Review official FDA meeting minutes with Scientific Advisory Board
–Finalize Femprox Product Plan
–Initiate any planned supportive studies
–Complete Femprox Room-Temperature device design
–Complete second round of Femprox market research
–Update market on Femprox Product Plan in Q4 2013
• FDA Feedback
• Clinical Development Plan
• Commercial Assessment
• Timelines