PHARMACY

FDA approves first new morning sickness pill in 30 years

BY Alaric DeArment

ROSEMONT, Pa. — The Food and Drug Administration has approved a drug for treating nausea and vomiting during pregnancy.

Drug maker Duchesnay USA said the FDA approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets in the 10 mg/10 mg strength for NVP, more commonly known as morning sickness, in women who don’t respond to conservative treatment. NVP is estimated to affect 70-85% of pregnant women, and symptoms range from nausea to severe vomiting and retching that can last throughout the day.

The company said Diclegis was the first FDA-approved treatment for morning sickness in more than 30 years.

"The FDA approval of Diclegis provides an important new treatment to the millions of women suffering from nausea and vomiting of pregnancy and fills a 30-year void in the treatment of NVP," Duchesnay CEO Gilbert Godin said. "Duchesnay USA is honored to bring the only FDA-approved treatment to help control symptoms of morning sickness to market."


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Patients taking AstraZeneca RA drug show partial improvement

BY Alaric DeArment

NEW YORK — An experimental drug developed by AstraZeneca for rheumatoid arthritis produced mixed results in measurements of patients’ conditions, according to results of a late-stage clinical trial.

AstraZeneca announced initial results of the phase-3 "OSKIRA-1" trial of fostamatinib, which it calls the first oral spleen tyrosine kinase inhibitor in development for RA.

The goals of the study were to measure signs and symptoms of RA based on two measures, known as ACR20 and mTSS after 24 weeks of treatment. The ACR20 measure indicated statistically significant improvement in patients’ conditions compared with those who took placebo, while mTSS did not.

ACR20, which stands for American College of Rheumatology 20, means a patient has at least 20% fewer tender joints and at least 20% fewer swollen joints, as well as 20% improvement in various assessments of the patient’s condition. The mTSS, which stands for modified total sharp score, measures bone erosion and joint-space narrowing using X-rays.

 

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Specialty pharmacy conference brings together industry experts

BY Alaric DeArment

NEW YORK — A joint conference by the National Association of Specialty Pharmacy and the Association of Managed Care Pharmacy attracted hundreds of leaders from across the specialty pharmacy industry.

The conference, which took place last week in San Diego, included a panel discussion on specialty medical benefit management for immunoglobulin products, with panelists who included Walgreens Specialty Pharmacy director of utilization management Michael Einodshofer, Wellpoint staff VP Ann Nguyen, Express Scripts VP and clinical practice lead for specialty Mary Dorholt and AxelaCare Health VP payer relations and contracting Michael Baldzicki, with Avalere Health SVP product commercialization and reimbursement Lauren Barnes acting as moderator.

The event also included a panel that offered an overview of specialty pharmacy, including current trends in the industry, a review of the drug pipeline and discussions about financial models, stakeholder expectations and other issues. The panel included RJ Health Systems CEO John Aforismo and AltoMetrixs principal Steve Lagano.

A specialty pharmacy benefit management discussion on hepatitis C addressed benefit design options and challenges, formulary and product selection criteria, tactics in utilization management and other issues, with Diplomat Specialty Pharmacy senior director of business development and industry relations Cheryl Allen, MHA Specialty Pharmacy VP specialty pharmacy solutions Erik Halstrom, Gilead Sciences VP managed markets Coy Stout, Acro Pharmaceutical Services director of business development David Coury and SelectHealth manager of pharmacy services Matthew Mitchell as panelists and Rxperts president Debbie Stern as moderator.

A session on the evolution of the community pharmacist to specialty pharmacist sought to help attendees learn the educational requirements necessary to best serve specialty patients and other important information and included Community Specialty Pharmacy Network VP industry relations Nick Calla, National Association of Specialty Pharmacy founder and CEO Gary Cohen and URAC senior manager for product development Terri Smith Moore.

Zitter Group CEO Mark Zitter served as moderator for the specialty key stakeholder panel discussion, which also included Diplomat Specialty Pharmacy SVP sales and business development Atheer Kaddis, Acro Pharmaceutical Services president Sajid Syed, Blue Cross Blue Shield of Michigan VP pharmacy services James Lang, CuraScript VP specialty payer account management and clinical services Jann Rigell and Institute for Integrated Healthcare and Bentelligence principal F. Randy Vogenberg.

Zitter also moderated a specialty pharmacy channel discussion that included Walgreens corporate VP specialty pharmacy and infusion Mike Ellis, National Community Pharmacists Association SVP strategic initiatives Kurt Proctor, Fairview Pharmacy Services director of business development Thomas Blissenbach and Onco360 CEO Burt Zweigenhaft.

"It’s All About the Patient" – Gaps in Care For the Specialty Patient focused on identifying and correcting gaps in patient care and discussing collaboration opportunities to enhance patient care. Pfizer Specialty Care VP U.S. specialty payer and channel group Diane Sullivan moderated the panel, which included Catamaran VP and chief pharmacy officer David Calabrese, MVP Health Care VP pharmacy services James Hopsicker, CareMed Pharmaceutical Services VP sales and marketing and network implementation John Witkowski, Biologics chief business development officer Daniel Duffy and U.S. Bioservices VP business development Keith McGee.

Another panel focused on the effects of the Patient Protection and Affordable Care Act on specialty, particularly how healthcare reform at various levels of government is leading to a "major paradigm shift" for healthcare delivery systems. NASP professional affairs head Jim Smeeding moderated the panel, which included Avalere Health SVP product commercialization and reimbursement Lauren Barnes, Sharp Rees-Stealy Medical Group president and medical director Donald Balfour and Xcenda president Brian Nightengale.

Lastly, a panel moderated by Diplomat VP information technology and marketing Jennifer Cretu discussed how healthcare IT could improve specialty patient outcomes. The panel included Remedy Informatics VP medical affairs Chad Malone, Creehan and Co. president Sean Creehan, Genentech medical director Thomas Morrow, Cardinal Health VP and CMO for specialty solutions and clinical pathways Bruce Feinberg and Axelacare chief marketing officer David Schaefer.

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