Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci - LARVOL DELTA

Contraception updates for adolescents. (PubMed, Curr Opin Pediatr) - "Updated evidence-based guidelines and several new contraceptive options should empower providers to provide patient-centered contraception counseling to patients with a variety of health conditions and contraceptive preferences."

Journal • Infectious Disease • Long-acting Reversible Contraceptives • Novel Coronavirus Disease • Pain

Evofem Expects Significant Reduction in PHEXXI Manufacturing Cost Through Agreement with Windtree Therapeutics (PRNewswire) - "Evofem Biosciences, Inc...today announced that it has entered into a License and Supply Agreement (L&S Agreement) with Windtree Therapeutics, Inc...under which Windtree will be Evofem's sourcing partner for PHEXXI (lactic acid, citric acid and potassium bitartrate)....Under the L&S Agreement, Windtree will leverage its manufacturing contacts to reduce the cost to manufacture PHEXXI. Evofem expects PHEXXI COGS will decrease by 55% to 60% from current levels. Furthermore, there will be no cost to Evofem for the tech transfer to the new manufacturer engaged by Windtree."

Commercial • Women's Health

Windtree Announces License and Supply Agreement to Become Sourcing Partner for a Small Biotech with an FDA Approved Product (GlobeNewswire) - "Windtree Therapeutics, Inc...is pleased to announce that it has entered into a License and Supply Agreement to become the sourcing partner for Evofem Biosciences, Inc...for one of Evofem’s FDA-approved products -- PHEXXI (lactic acid, citric acid and potassium bitartrate)...Windtree has manufacturing contacts that we believe are capable of reducing pharmaceutical product cost of goods for PHEXXI."

Licensing / partnership • Women's Health

Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: Queen's Medical Center | Trial completion date: Jun 2023 ➔ Dec 2025 | Trial primary completion date: Jun 2023 ➔ Oct 2025

Trial completion date • Trial primary completion date • Candidiasis • Vaginitis

EVOGUARD: Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection (clinicaltrials.gov) - P3 | N=1892 | Completed | Sponsor: Evofem Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Sexual Satisfaction Results with the Vaginal pH Modulator from the Phase 3 AMPOWER Study. (PubMed, J Sex Med) - "As a non-hormonal, woman-controlled, on-demand, lubricating contraceptive gel, VPM offers women a unique set of benefits with positive impacts on their sexual health."

Clinical • Journal • P3 data • Mood Disorders • Pain • Psychiatry

"$EVFM Evofem Wins Phexxi Coverage with Largest Payer in New York with No Prior Authorization Required https://t.co/GMPGe1A19H" (@stock_titan)

Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: Queen's Medical Center

New P1 trial • Candidiasis • Vaginitis

"$EVFM Evofem's Phexxi Contraceptive Gel to be Offered by Female Telehealth Leader Favor (Formerly The Pill Club) https://t.co/QrRXffbPQn" (@stock_titan)

"$EVFM Multiple New Insurance Wins Expand and Improve Access to Phexxi® for Millions of Women https://t.co/jnhJJ5Yfuk" (@stock_titan)

Reimbursement • US reimbursement

PREGNANCIES BY ACTS OF INTERCOURSE WITH VAGINAL PH MODULATOR: RESULTS FROM THE AMPOWER STUDY (ASRM 2022) - P3 | "OBJECTIVE: Vaginal pH modulator (VPM; Phexxi®) is a non-hormonal, woman-controlled gel for prevention of pregnancy... This post hoc analysis demonstrates that VPM users had a >99% chance of not getting pregnant at each act of intercourse. IMPACT STATEMENT: When providing counseling to women, these findings may serve as an additional tool to describe the efficacy of VPM to complement the Kaplan-Meier assessment."

Evofem Announces Issuance of U.S. Patent Covering Phexxi Composition of Matter (PRNewswire) - "At a medical conference this week, Leandro Mena...said, 'It is imperative that we...work to rebuild, innovate, and expand [STD] prevention in the U.S.'....Mena notes that a decrease in condom usage, particularly among young people, is fueling the rising rates."

Media quote

Lactic acid, citric acid and potassium bitartrate non-hormonal prescription vaginal pH modulator (VPM) gel for the prevention of pregnancy. (PubMed, Expert Rev Clin Pharmacol) - "A non-hormonal prescription vaginal pH modulator (VPM) gel (Phexxi®), with active ingredients lactic acid, citric acid and potassium bitartrate, has recently been approved for prevention of pregnancy in the United States...Spermicides, which improve efficacy of barrier devices, may increase the risk of HIV/STIs. VPM gel provides a new safe, effective non-hormonal contraceptive option, with potential for prevention of STIs."

Journal • Human Immunodeficiency Virus • Infectious Disease • Long-acting Reversible Contraceptives

"Will @Merck step up and buy and mass produce #phexxi to help women post-Roe? Will @pfizer ?" (@NotoriousWMG)

New Contraception Update - Annovera, Phexxi, Slynd, and Twirla. (PubMed, Curr Obstet Gynecol Rep) - "Lastly, Twirla is a transdermal patch releasing ethinyl estradiol and levonorgestrel that offers users an additional option for a user-controlled, combined hormonal contraceptive method without daily dosing; however, prescription is limited to patients with BMI < 30 kg/m due to decreased efficacy and VTE events in people with obesity. The addition of these products expands the available options for pregnancy prevention to address unmet contraceptive needs."

Journal • Genetic Disorders • Infectious Disease • Obesity • Urology

"$EVFM Evofem Reaches Agreement with One of the Largest Pharmacy Benefit Managers in the U.S. for Access to Phexxi® https://t.co/u3Innuxo4B" (@stock_titan)

M&A

Characterization of Women Who Experienced Urinary Tract Infections in the Phase 3 AMPOWER Trial (ACOG 2022) - P3 | "INTRODUCTION: Vaginal pH modulator (VPM; Phexxi) is a non-hormonal, on-demand, woman-controlled gel for the prevention of pregnancy... Compared to the overall AMPOWER population, women who experienced on-study UTIs had similar baseline characteristics and slightly lower product use."

Clinical • P3 data • Infectious Disease • Nephrology