Benzodiazepines are the gold standard for the treatment of insomnia. However, because of their potential for pharmacologic dependence and withdrawal reactions upon discontinuation, they are neither recommended or FDA-approved for chronic use. The novel cyclopyrrolone eszopiclone (es zoe pik? lone) (Estorra, Sepracor) is a stereoselective isomer of the agent zopiclone, which has been available in Europe for more than a decade. Clinical trials in patients with chronic insomnia suggest the medication may help manage both transient and chronic insomnia with minimal side effects. The most commonly reported side effect with the agent is a bitter taste. The apparent efficacy and favorable side effect profile together with its potential for obtaining the first indication for the management of chronic insomnia in the United States make eszopiclone an attractive therapeutic option. If the drug is approved by FDA, a key issue for formulary decision-makers will be whether to make it openly available or through prior authorization for specific clinical situations. Eszopiclone?s pricing may ultimately determine its use by clinical psychiatrists and reimbursement by insurers.
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
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David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
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