Breaking News
December 19, 2018 - RNA sequencing offers novel insights into the microbiome
December 19, 2018 - A promising, effective vaccine for common respiratory disease
December 19, 2018 - Protein may slow progression of emphysema, study finds
December 19, 2018 - Studying atrial fibrillation — and exploring new frontiers in precision health
December 19, 2018 - A New Way To Get College Students Through A Psychiatric Crisis — And Back To School
December 19, 2018 - Optum, UnitedHealthcare take action to help people affected by North Carolina winter storms
December 18, 2018 - Weight change in middle-aged, elderly Chinese Singaporeans related to increased risk of death
December 18, 2018 - Immune cells sacrifice themselves to protect us from invading bacteria
December 18, 2018 - Watching brain cells fire, with a twist of gravitational waves
December 18, 2018 - 2018 in Review
December 18, 2018 - Getting the Most Out of the CLARITY Technique
December 18, 2018 - NVF shoes provide a viable option for track and road racing
December 18, 2018 - CRISPR may restore effectiveness of chemotherapies used to treat lung cancer
December 18, 2018 - New app accurately measures and charts progression of skin wounds
December 18, 2018 - Persistent Discrimination ID’d Among Physician Mothers
December 18, 2018 - Cellphone technology developed to detect HIV
December 18, 2018 - A Stanford doctor hits the field with the 49ers — as their airway management physician
December 18, 2018 - The Rise of Anxiety Baking
December 18, 2018 - Just one night of sleep deprivation increases the urge to eat
December 18, 2018 - Study reveals mechanism behind failed remyelination in MS
December 18, 2018 - New genetic testing method increases the precision of biomarker analysis
December 18, 2018 - Simple technique to effectively treat underdiagnosed cause of debilitating chest pain
December 18, 2018 - Barbershop-based medical intervention can successfully lower blood pressure, new data shows
December 18, 2018 - Food labels have caused changes in consumers’ intake and industry’s use of key additives
December 18, 2018 - Sickest children could benefit from split liver transplants
December 18, 2018 - Scientists create patient-specific model to identify most effective treatment for appendix cancer
December 18, 2018 - ‘Little Foot’ endocast reveals a small brain combining ape-like and human-like features
December 18, 2018 - New therapy for childhood blindness shows ‘very promising’ results
December 18, 2018 - Researchers discover promising new compound against Buruli ulcer
December 18, 2018 - Study finds significant use of traditional, complementary and alternative medicines in Sub-Saharan Africa
December 18, 2018 - California Farm Implicated in Outbreak of E. coli Tied to Romaine Lettuce
December 18, 2018 - Mobile health has power to transform HIV/AIDS nursing
December 18, 2018 - Celiac Vaccine in Clinical Trials at Columbia
December 18, 2018 - Research into mental health first aid prompts practical guidance and resources for workplace
December 18, 2018 - Researcher conducts study to investigate peripheral blood markers of Alzheimer’s disease
December 18, 2018 - Researchers identify link between mucus in the small airways and pulmonary fibrosis
December 18, 2018 - EU Commission’s Health Policy Platform to host EKHA program on transplantation
December 18, 2018 - Survivors of childhood Hodgkin lymphoma have high risk of developing solid tumors
December 18, 2018 - Small changes to cafeteria design can get kids to eat healthier, new assessment tool finds
December 18, 2018 - From Machines to Cyclic Compounds
December 18, 2018 - New study reveals best assessment tools to establish delirium severity
December 18, 2018 - Rice University scientists develop synthetic protein switches to control electron flow
December 18, 2018 - Home-based pulmonary function monitoring for teens with Duchenne muscular dystrophy
December 18, 2018 - Researchers identify potential target for new breast cancer treatments
December 18, 2018 - National Biofilms Innovation Centre award grant to Neem Biotech for novel anti-biofilm drug development
December 18, 2018 - Artificial intelligence and the future of medicine
December 18, 2018 - Montana State doctoral student receives grant for her work to improve neuroscience tool
December 18, 2018 - Early postpartum initiation of opioids associated with persistent use
December 18, 2018 - Russian scientists identify molecular ‘switch’ that could be target for treatment of allergic asthma
December 18, 2018 - Surgeons make more mistakes in the operating room during stressful moments, shows study
December 18, 2018 - Immune cells explode themselves to inform about the danger of invading bacteria
December 18, 2018 - Malnutrition in children with Crohn’s disease linked with increased risk of surgical complications
December 18, 2018 - FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC)
December 18, 2018 - The long and short of CDK12
December 18, 2018 - Hologic’s Cynosure division introduces TempSure Surgical RF technology in North America
December 18, 2018 - CMR Surgical partners with Nicholson Center to launch U.S.-based training program for Versius
December 18, 2018 - Findings reinforce guidelines for cautious use of antipsychotics in younger populations
December 18, 2018 - Study finds new strains of hepatitis C virus in sub-Saharan Africa
December 18, 2018 - New battery-free, implantable device aids weight loss
December 18, 2018 - Parental alcohol use disorder associated with offspring marital outcomes
December 18, 2018 - Novel Breast Imaging Technique Might Cut Unnecessary Biopsies
December 18, 2018 - What can a snowflake teach us about how cancer spreads in the body?
December 18, 2018 - Management of nausea and vomiting in pregnancy costs the NHS more than previously thought
December 18, 2018 - Green leafy vegetables may reduce risk of developing liver steatosis
December 18, 2018 - Veganism linked to nutrient deficiencies and malnutrition if not planned correctly
December 18, 2018 - Coming Soon: A Tiny Robot You Swallow to Help You Stay Healthy
December 18, 2018 - Modified malaria drug proven effective at inhibiting Ebola
December 18, 2018 - Study finds epigenetic differences in the brains of individuals with schizophrenia
December 18, 2018 - Fitness instructors’ motivational comments influence women’s body satisfaction
December 18, 2018 - Study focuses on modification of lipid nanoparticles for successful brain cell targeting
December 18, 2018 - New gut bacteria may be effective against obesity, metabolic and mental disorders
December 18, 2018 - New two-in-one powder aerosol to upgrade fight against deadly superbugs in lungs
December 18, 2018 - Biofilms feed with swirling flows
December 17, 2018 - Study identifies specific neurological changes related to traumatic brain injury
December 17, 2018 - New study confirms geographic bias in lung allocation for transplant
December 17, 2018 - Research focuses on optimization of solid lipid nanoparticle that encapsulates Vinorelbine bitartrate
December 17, 2018 - Carpal tunnel syndrome – Genetics Home Reference
December 17, 2018 - A novel insulin accelerant
December 17, 2018 - Tips for caring for patients with disabilities, from a mother and physician
December 17, 2018 - Menopause-related sexual, urinary problems tied to worse quality of life
FDA Accepts Filing of New Estrogen-free Oral Contraceptive Slinda (drospirenone) Developed by Exeltis

FDA Accepts Filing of New Estrogen-free Oral Contraceptive Slinda (drospirenone) Developed by Exeltis

image_pdfDownload PDFimage_print

Treatment for Contraception

FDA Accepts Filing of New Estrogen-free Oral Contraceptive Slinda (drospirenone) Developed by Exeltis

FLORHAM PARK, New Jersey, November 29, 2018 /PRNewswire/ — The pharmaceutical multinational Exeltis, with a strong position in Women’s Health, has received acceptance from the US Food and Drug Administration (FDA) of the filing of Slinda (4mg Drospirenone-only pill), the novel oral contraceptive developed by the company. The Prescription Drug User Fee Act (PDUFA) date is expected during the 27 May of 2019.

Slinda is an investigational estrogen-free oral contraceptive, with a 24/4 dose regimen that is believed to have a favourable safety and efficacy profile.

“Developed by Exeltis, part of the global pharmaceutical group Insud Pharma, Slinda® showed to be safe, efficacious and well tolerated during extensive clinical trials. Once available in the market, it could give an improved bleeding profile and greater flexibility, maintaining contraception efficacy for up to 24 hours in the event of a delayed or missed pill dosage,” said Yann Brun, Managing Director Exeltis.

Drospirenone is a synthetic progestin with a pharmacological profile similar to natural-produced progesterone. As an estrogen-free contraceptive option, Slinda is expected to reduce the cardiovascular risks associated with Combined Hormonal Contraceptives (CHCs) and to offer all the unique advantages of drospirenone in terms of safety and tolerability and antimineralocorticoid and antiandrogenic activity.

“We are delighted that Slinda brings us one step closer to providing women in the United States with a new effective, safe and well-tolerated method of contraception,” commented Salustiano Perez, President Exeltis USA.

The submission of Slinda is based on an extensive development programme involving more than 3,000 patients, generating over 20,000 cycles. The study showed that Drospirenone 4 mg-only pill has a clinical efficacy historically comparable to CHCs. “No cases of thromboembolic events were reported in the entire clinical programme. The safety profile was demonstrated for all women, even higher-risk population segments, such as smokers, over-35s and obese patients,” said Enrico Colli, MD, Chief Scientific Officer.

Bleeding profile and novel dosing regimen 

According to the results shown in the clinical study, Drospirenone 4mg-only pill may offer a more favourable bleeding profile than other estrogen-free contraceptives.

Slinda is intended to give greater flexibility than other estrogen-free contraceptives, having demonstrated that in case of missing a pill, there is no impact in the efficacy during the following 24 hours, while with other estrogen-free options this is reduced to 12 hours.

About Exeltis 

Exeltis is fast growing division of Insud Pharma, an integrated health sciences group. It has developed a leading position in the Women’s Health sector, where it continues to innovate and seek new medicines and devices to improve the health and wellbeing of Women around the world. With a geographical footprint spanning over 40 countries, Exeltis employs over 4,000 professionals supported by a global production network. Exeltis strives to provide care for women throughout their lives. Exeltis offers a broad portfolio of products to respond to patients’ needs in the field of fertility, reproductive health, contraception, pregnancy, birth, and menopause and has expanded its reach in recent years to CNS, Ophthalmology and Endocrinology.

SOURCE Exeltis

Posted: November 2018

Slinda (drospirenone) FDA Approval History

Tagged with:

About author