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    3.  » FDA Approve Symbiomix’s Solosec™; Follows Four-Year Collaboration with Catalent
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Catalent Pharma Solutions today welcomed Symbiomix Therapeutics’ announcement that the U.S. Food and Drug Administration (FDA) has approved Solosec™ (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.

Catalent to Provide Developmental Support and Manufacturing

SOMERSET, N.J. – October 2, 2017 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today welcomed Symbiomix Therapeutics’ announcement that the U.S. Food and Drug Administration (FDA) has approved Solosec™ (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. [1] Catalent began working with Symbiomix in 2014 to improve the manufacturing process, and developed a scalable and robust method centered on its expertise in fluid bed coating technology, which is being utilized in manufacturing operations.

Solosec™, a next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, is the first and only single-dose oral therapy for BV, the most common gynecologic infection in the U.S. [1,2] Following FDA approval on September 15, 2017, Solosec™ is expected to be available to patients in early 2018 with at least 10 years of U.S. market exclusivity.

“The FDA’s approval of this new drug marks the culmination of many years of hard work, expertise and dedication by Symbiomix, with support from Catalent’s formulation development team in Somerset,” commented Jonathan Arnold, Catalent’s ‎vice president and general manager, Drug Delivery Solutions. “We have been able to leverage our skills in fluid bed coating at manufacturing scale to assist in bringing this first-of-its-kind therapy to the market, quickly and effectively.”

BV is the most prevalent gynecologic infection in the U.S., affecting 21 million women ages 14 to 49. According to the Centers for Disease Control and Prevention (CDC), if left untreated, BV increases the risk of transmission of sexually transmitted diseases, including chlamydia, trichomaniasis, gonorrhea, herpes and HIV, and increases the risk of pre-term birth and low birth weight. [2,3]

“Our partnership with Catalent was pivotal in the development of the first and only single-dose oral therapy for BV,” said Robert Jacks, President & CFO of Symbiomix. “Symbiomix is focused on bringing innovative therapies to market for prevalent gynecologic infections that can have serious health consequences, and we are thrilled to provide women with a new, effective treatment option that can be taken any time of day.”

Catalent provided services to Symbiomix at its 260,000-square foot facility in Somerset, which houses state-of-the-art development laboratories, as well as clinical and commercial manufacturing plants for oral dose forms.

Indication

SOLOSEC™ (secnidazole) 2g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women.

Important Safety Information

  • SOLOSEC is contraindicated in patients with a history of hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives. 
  • Vulvo-vaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
  • Potential risk of carcinogenicity in patients taking single-dose of SOLOSEC to treat bacterial vaginosis is unclear. Chronic use should be avoided. 
  • SOLOSEC may pass into breast milk. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.
  • SOLOSEC is a single-dose therapy for oral use. The entire contents of SOLOSEC packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. SOLOSEC is not intended to be dissolved in any liquid.
  • In clinical studies, the most common adverse events occurring in (≥2%) of patients receiving SOLOSEC 2g oral granules were vulvovaginal candidiasis (9.6%), headache (3.6%), nausea (3.6%), dysgeusia (3.4%), vomiting (2.5%), diarrhea (2.5%), abdominal pain (2.0%), and vulvovaginal pruritus (2.0%).

To report SUSPECTED ADVERSE REACTIONS, contact Symbiomix Therapeutics at 1-844-SOLOSEC (1-844-765-6732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please visit www.solosec.com for full Prescribing Information.

Media Contacts:

Chris Halling
+44 (0)7580 041073
chris.halling@catalent.com

Richard Kerns
+44 (0)161 728 5880
richard@nepr.eu

About Symbiomix Therapeutics, LLC

Symbiomix (sim-bye-OH-mix) Therapeutics is a biopharmaceutical company focused exclusively on bringing innovative therapies to market for prevalent gynecologic infections that can have serious health consequences. The Company received FDA approval for Solosec™ (secnidazole) 2g oral granules, the first and only single-dose therapy for the treatment of bacterial vaginosis (BV) in adult women.Symbiomix was founded in 2012 by a team of experienced industry professionals and entrepreneurs and is backed by three of the world’s leading healthcare venture capital firms: OrbiMed, F-Prime Capital Partners, and HBM Partners. Symbiomix is based in New Jersey, with additional offices in Maryland and Connecticut. Please visit https://symbiomix.com/ and follow the Company on LinkedIn and Twitter for more information.

About Catalent

Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2017 generated more than $2 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

More products. Better treatments. Reliably supplied.™

References

1. Solosec [Package Insert]. Newark, NJ: Symbiomix Therapeutics. 

2. Koumans E.H., Sternberg M, Bruce C, et al. (2007) “The Prevalence of Bacterial Vaginosis in the United States, 2001-2004: Associations with Symptoms, Sexual Behaviors, and Reproductive Health.” Sex Transm Dis. 34(11): 864-869.

3. https://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm.

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