Sprout Pharmaceuticals, Inc
Sprout Pharmaceuticals is dedicated to women's sexual health, focusing on innovative treatments for conditions like Hypoactive Sexual Desire Disorder (HSDD). They are committed to advancing women's health through research, clinical trials, and providing FDA-approved treatment options such as Addyi. The company fosters a culture of being untraditional, bold, and appreciative, aiming to make a significant impact in women's sexual wellness.
Industries
Nr. of Employees
small (1-50)
Sprout Pharmaceuticals, Inc
4350 Lassiter at North Hills Ave #260, Raleigh, NC 27609
Patents
Products
Oral non-hormonal pill for acquired, generalized HSDD in premenopausal women
An orally administered, non-hormonal treatment indicated for acquired, generalized hypoactive sexual desire disorder in premenopausal women; demonstrated in clinical trials to increase desire, number of satisfying sexual events, and reduce related distress, with common adverse effects including dizziness, somnolence, nausea, fatigue, insomnia and dry mouth.
Oral non-hormonal pill for acquired, generalized HSDD in premenopausal women
An orally administered, non-hormonal treatment indicated for acquired, generalized hypoactive sexual desire disorder in premenopausal women; demonstrated in clinical trials to increase desire, number of satisfying sexual events, and reduce related distress, with common adverse effects including dizziness, somnolence, nausea, fatigue, insomnia and dry mouth.
Services
Provision of medical information, promotional material review, congress activities, publication planning, and support for investigator interactions.
Review and facilitation of investigator-initiated research via a formal concept proposal form and administrative review process.
Operational management of sponsored clinical studies including protocol support, contracting, drug supply logistics, and data management oversight.
Preparation and submission of regulatory documents, management of labeling changes and REMS modifications, and liaison with regulatory authorities.
Development and maintenance of digital patient/HCP engagement platforms, frontend web applications, and integration with CRM and marketing tools.
Provision of medical information, promotional material review, congress activities, publication planning, and support for investigator interactions.
Review and facilitation of investigator-initiated research via a formal concept proposal form and administrative review process.
Operational management of sponsored clinical studies including protocol support, contracting, drug supply logistics, and data management oversight.
Preparation and submission of regulatory documents, management of labeling changes and REMS modifications, and liaison with regulatory authorities.
Development and maintenance of digital patient/HCP engagement platforms, frontend web applications, and integration with CRM and marketing tools.
Expertise Areas
- Clinical trial management
- Medical affairs and scientific communications
- Pharmacovigilance and safety surveillance
- Regulatory strategy and labeling
Key Technologies
- Randomized, placebo-controlled clinical trials
- Observational pregnancy registries
- Risk Evaluation and Mitigation Strategy (REMS) implementation
- Validated patient-reported outcome instruments (FSFI)
News & Updates
Searchlight Pharma announced the availability of Addyi® in Canada for the treatment of HSDD in premenopausal women, acquiring rights via licensing from Sprout Pharmaceuticals.
New data from three alcohol interaction studies show no syncope or orthostatic hypotension requiring medical attention, clarifying Addyi's safety profile.
The FDA has decided that existing warnings about alcohol use with Addyi are overly restrictive based on new studies, and is working with Sprout to update labeling.
Searchlight Pharma announced the availability of Addyi® in Canada for the treatment of HSDD in premenopausal women, acquiring rights via licensing from Sprout Pharmaceuticals.
New data from three alcohol interaction studies show no syncope or orthostatic hypotension requiring medical attention, clarifying Addyi's safety profile.
The FDA has decided that existing warnings about alcohol use with Addyi are overly restrictive based on new studies, and is working with Sprout to update labeling.