Navigation Links
S1 Pharmaceuticals Announces IND Filing of SIP-104 (Lorexys) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
Date:2/21/2012

JERSEY CITY, N.J., Feb. 21, 2012 /PRNewswire/ -- S1 Pharmaceuticals, Inc. (S1) announced today that it has submitted its Investigational New Drug (IND) application to the U.S. Food and Drug Administration for Phase I-b clinical studies of SIP-104 (Lorexys).  Lorexys is the Company's lead drug candidate for the treatment of Hypoactive Sexual Desire Disorder (HSDD) and Female Sexual Dysfunction (FSD). 

Lorexys' clinical development plan is based on pharmacokinetic and safety data for a 505(b)(2) New Drug Application (NDA).  Lorexys is a novel use fixed-dose combination (FDC) in an oral enteric formulation acting on the central nervous system (CNS) with therapeutic characteristics that benefit sufferers of sexual health disorders.  It is intended as a treatment for HSDD both as a standalone and as an adjunct to testosterone therapy for the disorder.

"The IND filing for Lorexys is an important milestone for our Company," stated Nicolas G. Sitchon, Chief Executive Officer. "The Lorexys Clinical Development Program represents S1's entry into the significant Women's Sexual Health Disorders field with a lead drug candidate having several potential advantages over other treatment options in development."

On the condition of FDA endorsement of an approvable Investigational New Drug application for Lorexys, the Company will conduct Multiple Ascending Dose (MAD) safety, tolerability, and exploratory efficacy Phase I-b studies on Lorexys in 2012.  Upon successful completion, the results from these studies will satisfy FDA requirements to commence Phase II studies for HSDD patients.

About S1 Pharmaceuticals, Inc.

S1 is an early-stage biopharmaceutical company developing therapeutic solutions for disorders of Women's Sexual Health.  The most common type of Female Sexual Dysfunction (FSD) is a distressing loss of libido (lack of sexual interest) known as Hypoactive Sexual Desire Disorder (HSDD).  S1 is developing its lead product, Lorexys, as an oral drug and will seek to demonstrate that Lorexys can be the first safe and effective treatment approved by the FDA for HSDD in women.

Contact:
press@s1pharma.com
(201) 839-0941


'/>"/>
SOURCE S1 Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Savient Pharmaceuticals to Present at the Citi 2012 Global Health Care Conference
2. Par Pharmaceutical Completes Acquisition of Edict Pharmaceuticals
3. Endo Pharmaceuticals to Present at J.P. Morgan Annual Global High Yield & Leveraged Finance Conference
4. Access Pharmaceuticals MuGard Added to Nationally Ranked Childrens Hospital of Colorado Pharmacy Formulary
5. Questcor Pharmaceuticals Appoints Scott M. Whitcup, M.D., to Board of Directors
6. Omthera Pharmaceuticals, Inc. to Present at Leerink Swann 2012 Global Healthcare Conference and Citi 2012 Global Healthcare Conference
7. Jazz Pharmaceuticals to Announce 2011 Full Year and Fourth Quarter Financial Results on February 27, 2012
8. Vanda Pharmaceuticals Reports Fourth Quarter 2011 and Full Year 2011 Results
9. Faruqi & Faruqi, LLP Announces Investigation of BioSante Pharmaceuticals, Inc.
10. Ampio Pharmaceuticals Reports Full-Year 2011 Financial Results and Milestone Highlights for 2011
11. Jubilant and Endo Pharmaceuticals Announce Successful Delivery of Early Milestones in Collaborative Discovery Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
(Date:6/24/2016)... According to a new market ... Needles, Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, ... of Purchase (Retail, Non-Retail) - Trends & Global Forecasts ... market for the forecast period of 2016 to 2021. ... by 2021 from USD 1.65 Billion in 2016, growing ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas ... , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct ...
(Date:6/24/2016)... ... , ... People across the U.S. are sharpening their pencils and honing their ... in which patients and their families pay tribute to a genetic counselor by nominating ... of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, ...
(Date:6/24/2016)... ... 24, 2016 , ... Puradigm® & Innovative Solutions today announced ... and processing operations at its production facility, and opened its first two dispensaries ... manufacturer of a complete system of proactive air and surface purification solutions for ...
(Date:6/24/2016)... ... , ... Venture Construction Group (VCG) sponsors Luke’s Wings ... the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. The event ... that have been wounded in battle and their families. Venture Construction Group is a ...
Breaking Medicine News(10 mins):