Twirla (ethinyl estradiol/levonorgestrel) / Corium, Insud Pharma - 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

Choice of contraceptives. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Long-acting Reversible Contraceptives • Venous Thromboembolism

"$AGRX Agile Therapeutics Provides Updates on 2022 Twirla Performance and 2023 Commercial Plan https://t.co/whB7lbCigu" (@stock_titan)

Extended regimen of a levonorgestrel/ethinyl estradiol transdermal delivery system: Predicted serum hormone levels using a population pharmacokinetic model. (PubMed, PLoS One) - P1 | "These results indicate that a 12-week extended LNG/EE regimen would provide similar systemic hormonal exposure as that seen by week 3 in a standard 28-day regimen, without further hormonal accumulation. The data support the safe use of a non-daily, low-dose hormonal contraceptive in an extended regimen but should be confirmed in a clinical PK study."

Clinical • Journal • PK/PD data

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

Postmarketing Safety of a Levonorgestrel/Ethinyl Estradiol Contraceptive Transdermal Delivery System (ACOG 2022) - "INTRODUCTION: TWIRLA is a low-dose contraceptive transdermal delivery system of 120 µg/day levonorgestrel and 30 µg/day ethinyl estradiol (LNG/EE TDS) used in a 28-day cycle... In this assessment of real-world usage of the LNG/EE TDS, SAEs and TDS replacements were infrequent and no VTEs were reported. These findings are consistent with the safety profile reported in the SECURE study, where four patients with VTEs were identified, all in women with a BMI >30 kg/m2."

Clinical • P4 data • Cardiovascular • Psychiatry • Suicidal Ideation • Venous Thromboembolism

"$AGRX Agile Therapeutics and Afaxys Partner to Expand Access to Twirla® (Levonorgestrel and Ethinyl Estradiol) Transdermal System https://t.co/j6RROhRvGS" (@stock_titan)

"$AGRX Agile Therapeutics Announces Addition of Twirla® to a Preferred Drug Position on Medi-Cal Formulary https://t.co/vJUrEBRjLX" (@stock_titan)

The new low-dose transdermal contraceptive system (Twirla): results from preclinical and Phase III trials. (PubMed, Ther Deliv) - "The rationale for developing this new patch, the preclinical study results and the results from two innovative Phase III clinical trials demonstrate that this patch has an acceptable Pearl index (4.3%) for its indicated users and has safety and tolerability comparable to other similar dose oral combined hormonal contraceptives. This new TDS provides an improvement over the existing TDS products, with significantly lower steady-state estrogen exposure, a level equal to that with 30-µg EE containing oral contraceptives."

Journal • P3 data • Preclinical • Long-acting Reversible Contraceptives

Twirla - a new contraceptive patch. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Long-acting Reversible Contraceptives

"$AGRX Agile Therapeutics Announces Nationwide Commercial Launch and Availability of Twirla® (levonorgestrel and ethinyl estradiol) Transdermal System, a New Non-Daily, Non-Invasive Contraceptive Patch https://t.co/3lmAhLY31w" (@stock_titan)

Efficacy, Safety, and Tolerability of a Levonorgestrel/Ethinyl Estradiol Transdermal Delivery System: Phase 3 Clinical Trial Results. (PubMed, Contraception) - "The low-dose LNG/EE TDS was effective in preventing pregnancy in a population of women representative of US demographics. Efficacy was reduced in women with BMI ≥30 kg/m. The TDS safety and tolerability profile was consistent with other similar dose combined hormonal contraceptives. Results of this phase 3 study supported the FDA approval of TWIRLA® for prevention of pregnancy in women with BMI <30 kg/m."

Clinical • Journal • P3 data • Cardiovascular • Pain

"Let's change the #obesity narrative--tonight! @MichelleCardel @eatrightfitness @DrGoodpaster @DrRobertKushner @greenhousemd @ECPObesity @FatDag @drteohsh @JeanineMSherman @IanPatton55 @HeartOTXHeartMD @LeeAnnKindness @twirlandswirl @labworknfitness @ObesityAdvocate @rpashbyphd" (@pattynece)

Genetic Disorders • Obesity

Phexxi - a nonhormonal contraceptive gel. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Long-acting Reversible Contraceptives

"Please join us tomorrow! We're chatting about #WeightBias. @hrdlckwmn @jameshamblin @JeanineMSherman @IanPatton55 @ASMBSIH @HeartOTXHeartMD @JasonKrynicki82 @JaniceAsherMD @jen4tri @LeeAnnKindness @twirlandswirl @DrSanDiego @CleopatraNik @rpashbyphd @OffThePlateMC @mcnee" (@pattynece)

Adhesion Evaluation of AG200-15: An Investigational Transdermal Contraceptive Delivery System. (PubMed, Adv Ther) - "The in vivo adhesion of AG200-15 is non-inferior to that of Xulane on the basis of the prespecified criterion of the upper bound of the one-sided 95% CL for the mean adhesion score difference being below + 0.15. Both patches were generally well tolerated."

Journal • Long-acting Reversible Contraceptives • Women's Health

"FDA Approves Weekly Contraceptive Patch Twirla https://t.co/S4eD16LbZL vía @medscape #contraception #women" (@harofe64)

Clinical • FDA event

".@US_FDA clears Agile Therapeutics' Twirla weekly contraceptive patch https://t.co/aKml9jSTQi #regulatory" (@RegProRecruit)

"@US_FDA approves #Twirla® from @AgileTher The once-a-week patch is a great addition to #BirthControl choices. #Contraception #Innovation #Skinfusion® @MylanNews" (@Dhammikax)

FDA event

"This is the third new drug application review cycle by the FDA for AG200-15. https://t.co/NJW2pDEbxD @Medscape" (@MassMedical)

NDA

"Pink Sheet Podcast: Twirla Adcom Surprise And Makena Adcom Questions https://t.co/zas2wGcJ6J #PinkSheet" (@PharmaPinkSheet)

"AG200-15 contraceptive patch overwhelmingly backed by FDA advisory panel despite significant concerns. https://t.co/aMOaZOY8W5" (@Medscape)

Agile Therapeutics Reports Second Quarter 2019 Financial Results (GlobeNewswire, Agile Therapeutics, Inc.) - "Agile Therapeutics, Inc...provided a corporate update...combined safety data from three Phase 3 studies of Twirla (AG200-15) was presented in an ePoster session at the 2019 Annual Clinical and Scientific Meeting of the American Congress of Obstetricians and Gynecologists (ACOG)."

Clinical • Clinical data

"Agile’s Twirla Heads To Advisory Committee: No Mystery Why https://t.co/sqmbYNZ7Xp #PinkSheet" (@PharmaPinkSheet)

Agile Therapeutics Announces FDA Advisory Committee Meeting for its Investigational Transdermal Low-Dose Contraceptive Patch, Twirla® (AG200-15) (GlobeNewswire, Agile Therapeutics, Inc.) - "Agile Therapeutics...today announced that a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for October 30, 2019, to review the Company’s New Drug Application (NDA) for its lead product candidate, Twirla® (AG200-15)....Agile resubmitted the NDA for Twirla (AG200-15) on May 16, 2019, and the FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 16, 2019, for the completion of its review of the Twirla (AG200-15) NDA."

Clinical • FDA event • NDA • P3 data • PDUFA date • Regulatory