Armodafinil

A $345 million settlement by Pfizer in 2021 didn't get the company completely off the hook regarding EpiPen antitrust allegations. Pfizer has recently agreed to pay another $50 million to direct purchasers who claimed that the company used anticompetitive practices, a court filing shows. Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief medicine. The lawsuit, which dates to 2020 and was brought in federal court in Kansas, was filed by direct purchaser plaintiffs who claimed Pfizer and its EpiPen marketing and distribution partner Mylan conspired with Teva to delay the entry of a generic version of EpiPen.  The settlement was revealed in a court filing this week. The suit claimed Mylan agreed to delay entry of its generic version of Teva’s branded blockbuster drug Nuvigil in exchange for Teva delaying entry of its EpiPen generic. The direct purchasers claimed they paid more for EpiPen than they would have if Teva’s generic was on the market. Under a prior partnership with Mylan, a Pfizer subsidiary was responsible for manufacturing EpiPen devices. Pfizer has since sold the subsidiary. "Pfizer has reached an agreement to fully resolve plaintiffs’ class action claims against Pfizer relating to a product no longer manufactured by the company. Pfizer denies any wrongdoing and continues to believe that its actions were appropriate," the company said in a statement. "This resolution, which is subject to court approval, reflects a desire by the company to avoid the distraction of continued litigation." The settlement is on top of a 2021 agreement by Pfizer to pay $345 million to resolve an antitrust suit brought in 2017 by indirect purchasers—such as insurers, consumers and pension funds—also in U.S. court in Kansas. That multi-district suit, which combined all U.S. cases into one, also centered on alleged anticompetitive conduct surrounding EpiPen. Over the span of several years, Mylan jacked up the price of the life-saving injectable medicine from $100 to $600, drawing outrage from consumers. In 2017, Mylan agreed to pay $465 million to resolve U.S. Justice Department claims it overcharged the Medicaid for EpiPen by misclassifying its device as a “generic.” Then in March of last year, Viatris paid $264 million to resolve a class-action suit brought by consumers and third-party payers alleging antitrust abuses on EpiPen. Viatris was formed in 2020 when Mylan combined with Pfizer’s generics unit Upjohn.

WEDNESDAY, May 10, 2023 -- For patients with obstructive sleep apnea (OSA), solriamfetol , armodafinil - modafinil , and pitolisant reduce daytime sleepiness, with solriamfetol likely superior, according to a systematic review and meta-analysis published online May 9 in the Annals of Internal Medicine . Tyler Pitre, M.D., from McMaster University in Hamilton, Ontario, Canada, and colleagues compared the effectiveness of drugs for excessive daytime sleepiness (EDS) in OSA in a network meta-analysis of 14 trials with 3,085 patients assigned to any pharmacologic intervention. The researchers found that solriamfetol improves Epworth Sleepiness Scale (ESS) scores compared with placebo at four weeks (mean difference, −3.85; high certainty), while armodafinil-modafinil and pitolisant-H3-autoreceptor blockers probably improve ESS scores (mean differences, −2.25 and −2.78, respectively; both moderate certainty). Solriamfetol and armodafinil-modafinil improve the Maintenance of Wakefulness Test compared with placebo at four weeks (standardized mean differences, 0.9 and 0.41, respectively; both high certainty), while pitolisant-H3-autoreceptor blockers probably do not (moderate certainty). Armodafinil-modafinil probably increases the risk for discontinuation due to adverse events at four weeks (relative risk, 2.01; moderate certainty), while the association for solriamfetol was not found to be significant. "Solriamfetol, armodafinil-modafinil, and pitolisant are effective therapies available to patients with OSA-associated EDS already on conventional therapy," the authors write. "Potential for long-term harm of all available pharmacotherapy remains unclear." Abstract/Full Text (subscription or payment may be required) Posted May 2023