Understanding the Patient Experience with Twice-Nightly Sodium Oxybate Therapy for Narcolepsy: A Social Listening Experiment.

Background/objectives: Narcolepsy is a chronic neurologic disorder associated with substantial challenges that affect the social, emotional, and financial quality-of-life domains. A social listening analysis and structured survey were conducted to better understand the candid perspective of people with narcolepsy (PWN) and their experience with twice-nightly sodium oxybate (SXB).

Methods: To characterize conversations and experiences in narcolepsy communities where SXB was mentioned, a social media analysis was conducted from August 2011 to October 2022.

RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates.

Objective/background: Preference for extended-release, once-nightly sodium oxybate (ON-SXB, FT218) vs twice-nightly immediate-release (IR) oxybate was assessed in participants switching from IR oxybate to ON-SXB in an open-label/switch study, RESTORE (NCT04451668).

Patients/methods: Participants aged ≥16 years with narcolepsy who completed the phase 3 REST-ON trial, were oxybate-naive, or were on a stable IR oxybate dose (≥1 month) were eligible for RESTORE. For participants who switched from twice-nightly dosing to ON-SXB, initial doses were closest or equivalent to their previous nightly IR oxybate dose.

Weight Loss With Once-nightly Sodium Oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial.

Purpose: Individuals with narcolepsy are more likely to be obese than the general population. Changes in weight-related measures with extended-release, once-nightly sodium oxybate (ON-SXB) and characteristics of participants with ≥5% weight loss were assessed in a Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) trial post hoc analysis.

Methods: REST-ON (NCT02720744) was a Phase III, double-blind, placebo-controlled, multicenter, randomized clinical trial.

Improvements in daytime sleepiness and disrupted nighttime sleep with once-nightly sodium oxybate in people with narcolepsy type 1 and type 2: a plain language summary.

What Is This Summary About?: This is a plain language summary of a published article in the journal . Narcolepsy is a sleep condition that has 2 different subtypes: narcolepsy type 1 and narcolepsy type 2. These are called NT1 and NT2 for short.

Improvement in sleep latency with extended-release once-nightly sodium oxybate for the treatment of adults with narcolepsy: Analysis from the phase 3 REST-ON clinical trial.

Background: In the REST-ON clinical trial (NCT02720744), mean sleep latency on the Maintenance of Wakefulness Test (MWT) was significantly improved with extended-release once-nightly sodium oxybate (ON-SXB) vs placebo ( < 0.001) in participants with narcolepsy. This post hoc analysis assessed response to treatment and improvement in excessive daytime sleepiness.

Cataplexy response with extended-release once-nightly sodium oxybate: Post hoc responder analyses from the phase 3 REST-ON clinical trial.

Background: Once-nightly sodium oxybate (ON-SXB), an extended-release oxybate formulation, yielded significant ( < 0.001 at 6 g, 7.5 g, and 9 g) reductions in cataplexy episodes in participants in the phase 3 REST-ON clinical trial (NCT02720744).

Once-nightly sodium oxybate (FT218) improved symptoms of disrupted nighttime sleep in people with narcolepsy: a plain language summary.

What Is This Summary About?: This is a plain language summary of a published article in the journal . Narcolepsy is a rare sleep condition. Most people with narcolepsy experience disrupted nighttime sleep and have poor quality of sleep.

Efficacy of once-nightly sodium oxybate (FT218) in narcolepsy type 1 and type 2: post hoc analysis from the Phase 3 REST-ON Trial.

Study Objectives: Post hoc analyses from the phase 3 REST-ON trial evaluated efficacy of extended-release once-nightly sodium oxybate (ON-SXB; FT218) vs placebo for daytime sleepiness and disrupted nighttime sleep in narcolepsy type 1 (NT1) and 2 (NT2).

Methods: Participants were stratified by narcolepsy type and randomized 1:1 to ON-SXB (4.5 g, week 1; 6 g, weeks 2-3; 7.

Clinician Preferences for Oxybate Treatment for Narcolepsy: Survey and Discrete Choice Experiment.

Introduction: Immediate-release sodium oxybate (SXB) has been Food and Drug Administration (FDA)-approved to treat narcolepsy since 2002; in 2020, a mixed-salt oxybates formulation was also approved. Both are taken at bedtime with a second dose taken 2.5-4 h later.

Evidence of Accidental Dosing Errors with Immediate-Release Sodium Oxybate: Data from the US Food and Drug Administration Adverse Event Reporting System.

Introduction: Sodium oxybate has been approved by the US Food and Drug Administration (FDA) to treat narcolepsy for 20 years; however, the only available products have been immediate-release (IR) formulations given twice nightly-once at bedtime and a second dose 2.5-4 h later-creating inherent risks with dosing administration errors.

Objectives: Evidence and risks associated with accidental ingestion of the second IR oxybate dose < 2.

Randomized, crossover, open-label study of the relative bioavailability and safety of FT218, a once-nightly sodium oxybate formulation: Phase 1 study in healthy volunteers.

Objectives: Treatment for narcolepsy with sodium oxybate (SXB) has required twice-nightly dosing, at bedtime and 2.5-4 h later. This study evaluated the pharmacokinetics of FT218, an investigational, extended-release, once-nightly formulation of SXB (ON-SXB), vs twice-nightly SXB.

Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth.

17-alpha-hydroxyprogesterone caproate (17P) has been in use for prevention of recurrent preterm birth since 2003 when the Meis trial was published. A requirement for Food and Drug Administration approval of 17P was a confirmatory trial, called "PROLONG", which was recently completed, but did not replicate the efficacy demonstrated in the Meis trial. This review analyzes the safety data from each trial, as well as integrated data from the two trials.

FDA approved vs. Pharmacy compounded 17-OHPC-current issues for obstetricians to consider in reducing recurrent preterm birth.

17α-hydroxyprogesterone caproate (17-OHPC; MAKENA and generic equivalents) is the only FDA-approved medicine available to reduce the risk of preterm birth (PTB) in pregnant women with a singleton pregnancy who have a history of singleton spontaneous PTB. The FDA held an Advisory Committee meeting in October 2019 to review conflicting data between one positive U.S.

Correction to: Communicating with African-American Women Who Have Had a Preterm Birth about Risks for Future Preterm Births.

The article [Communicating with African-American Women Who Have Had a Preterm Birth About Risks for Future Preterm Births], written by [Allison S. Bryant, Laura E. Riley, Donna Neale, Washington Hill, Theodore B.

Communicating with African-American Women Who Have Had a Preterm Birth About Risks for Future Preterm Births.

Purpose: African-American women are at higher risk of preterm birth (PTB) compared with other racial/ethnic groups in the USA. The primary objective was to evaluate the level of understanding among a group of African-American women concerning risks of PTB in future pregnancies. Secondary objectives were to evaluate how some women obtain information about PTB and to identify ways to raise their awareness.

17-OHPC to Prevent Recurrent Preterm Birth in Singleton Gestations (PROLONG Study): A Multicenter, International, Randomized Double-Blind Trial.

Background: Women with a history of spontaneous preterm birth (SPTB) are at a significantly increased risk for recurrent preterm birth (PTB). To date, only one large U.S.

Mode of injection and treatment adherence: results of a survey characterizing the perspectives of health care providers and US women 18-45 years old.

Purpose: A market research study was conducted to characterize perceptions of intramuscular (IM) and subcutaneous (SC) routes of injection, including use of autoinjectors, and how these perceptions affect adherence to injection regimens. The perspectives were from women of childbearing age (18-45 years old; consumers) and health care providers (HCPs) involved in women's health care.

Methods: Two telephone surveys, one of HCPs and the other of consumers, were conducted by KRC Research (New York, NY, USA) between May and July 2017.

Female Sexual Health: Barriers to Optimal Outcomes and a Roadmap for Improved Patient-Clinician Communications.

Background: Although sexual health can be considered a vital sign for overall health, several barriers prevent women from receiving proper medical counseling, support, and/or care for their sexual health needs and concerns.

Methods: Experts in sexual health compiled research and experience on the impediments to women receiving adequate assessment and treatment for their sexual health. Specific solutions and a roadmap for overcoming such barriers and improving patient-clinician communication are presented.

Understanding if, How, and Why Women with Prior Spontaneous Preterm Births are Treated with Progestogens: A National Survey of Obstetrician Practice Patterns.

 In 2017, the Society for Maternal-Fetal Medicine (SMFM) Guideline Committee reaffirmed that 17 -hydroxyprogesterone caproate (17-OHPC) to prevent preterm birth (PTB) is underutilized. We sought to determine what drove progestogen treatment choice of obstetricians managing pregnant women with histories of 1+ singleton spontaneous PTBs (< 37 weeks) who then delivered singleton gestations within the previous 12 months.  We recruited a nationally representative random sample of obstetricians to abstract medical records of study-qualified patients.

Potential risks of pharmacy compounding.

Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. Traditional pharmacy compounding is appropriate when done on a small scale by pharmacists who prepare the medication based on an individual prescription. However, the regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration (FDA)-approved drugs; as such, compounded drugs may pose additional risks to patients.