5 Headlines in Pharmacy This Week

1. Say goodbye to Clostridium difficile infections (CDI)!¹

The FDA has approved Zinplava (bezlotoxumab), a human monoclonal antibody that prevents the recurrence of CDI by neutralizing the C. difficile toxin B. The toxin is responsible for inflammation and damage to the gut wall, which leads to C. difficile enteritis symptoms (abdominal pain and watery diarrhea).

Bezlotoxumab is indicated in patients 18 years or older who currently take antibiotics for CDI and are at high risk of CDI recurrence. This medication isn’t used for the treatment of CDI and should only be used concurrently with antibiotics treatment of CDI.

The most common adverse effects that patients experienced in its 2 Phase 3 clinical trials (MODIFY I, MODIFY II) were nausea, pyrexia, and headache. The most serious adverse effect that patients reported was heart failure (2.3%), but that occurred primarily in patients with underlying congestive heart failure. Bezlotoxumab faces competition from Pfizer and Sanofi’s pipeline vaccines that prevent C. diff altogether. Merck hopes to make this medication available in early 2017.

2. Abuse-deterrent painkillers—the race to curb the opioid epidemic^2,3

Daiichi Sankyo and Inspirion Delivery Sciences have teamed up to commercialize MorphaBond, an abuse-deterrent formulation of morphine sulfate extended-release tablets. The new formulation is designed to prevent the medication from being broken up and dissolved in a liquid. It forms a viscous material when the medication is dissolved and, in turn, prevents the passage through a syringe. MorphaBond also incorporates SentryBond technology, which maintains the intended release profile of extended-release medications and delays its release of the immediate-release ingredients.

Daiichi Sankyo also has another 2 medications in its pain management pipeline, CL-108 and mirogabalin, which I think will very likely incorporate these abuse-deterrent properties. CL-108 is currently undergoing phase 3 testing and consists of hydrocodone 7.5 mg/APAP 325mg and promethazine 12.5 mg. The promethazine component is intended to inhibit nausea and vomiting, a common adverse effect that 40% of patients on opioid therapy experience. Mirogabalin is under development that will rival Lyrica (Pregabalin) and claims to be superior to and safer for the treatment of fibromyalgia and neuropathic pain from diabetes or herpesvirus infection.

3. Will the return Auvi-Q finally dethrone EpiPen?⁴

Last year, Sanofi recalled Auvi-Q due to inconsistent dosage delivery. Just this week, Kaléo assumed all rights to Auvi-Q and plans to re-launch the medication in the first half of 2017. Kaléo has incorporated an intensive manufacturing process that uses more than 100 quality checks along the production line and invested new technology and quality systems to ensure the accurate, reliable, and consistent delivery of the medication. Auvi-Q has great features such as its small and compact size and it incorporates voice instructions to guide patients through the process. However, the biggest concern patients will have is the price. Kaléo promises it will be an affordable alternative. In my opinion, this medication must be significantly cheaper than the EpiPen for it to be successful.

4. Lynparza (olaparib) shows promising data for its treatment of ovarian cancer⁵

AstraZeneca just announced positive results from olaparib’s phase 3 trial (SOLO-2) that further confirm its safety and efficacy profile. Olaparib is a PARP inhibitor that’s used as a monotherapy for the maintenance treatment of platinum-sensitive relapsed, BRCA-mutated ovarian cancer. It claims that its median progression-free survival substantially exceeded its previous trials. In its phase 2 results, patients experienced a median progression-free survival of 11.2 months, compared to only 4.3 months among placebo patients. Full results will be announced sometime soon.

These results are promising, but it faces stiff competition from Tesaro’s niraparib, also a PARP inhibitor. Niraparib showed a 21-month progression-free survival in its ENGOT-OV16/NOVA trial that was presented at the ESMO 2016 congress earlier this month.

5. Express Scripts gets handed subpoenas⁶

Express Scripts, the nation’s largest pharmacy benefit manager (PBM) has received multiple subpoenas in the past 2 months. Back in August, the US Attorney’s Office for the Southern District of New York asked for information about its relationships with drug companies and prescription drug plan clients and payments made to and from those entities.

Just last month, the Department of Justice and the US Attorney’s Office for the District of Massachusetts requested information about its relationship with drug manufacturers and independent 501(c)(3) charitable foundations providing cost-sharing assistance to federal health care program beneficiaries and specialty pharmacies. This has triggered federal investigators to look into Express Scripts’ relationship with pharmaceutical companies, charitable foundations, and specialty pharmacies.

PBMs act as the middlemen who negotiate medication pricing and pharmacy services with pharmaceutical manufacturers to secure discounts and rebates. There’s little to no transparency in this area. PBMs claim they’re getting patients the best prices with their closed-door negotiations; however, many Americans are actually paying double for their medications. I believe that within the next few years, PBMs will be fully exposed, and a lot of people are going to be upset. If you want to know how a PBM works, watch this quick video.

References

• Eisele P, Consalvo R. FDA approves Merck’s ZINPLAVA™ (bezlotoxumab) to reduce recurrence of Clostridium difficile infection (CDI) in adult patients receiving antibacterial drug treatment for CDI who are at high risk of CDI recurrence. mercknewsroom.com/news-release/corporate-news/fda-approves-mercks-zinplava-bezlotoxumab-reduce-recurrence-clostridium-. Accessed October 21, 2016.
• Taylor P. Daiichi Sankyo fleshes out priority pain platform with two abuse-resistant opioids. fiercepharma.com/pharma-asia/daiichi-sankyo-fleshes-out-priority-pain-platform-two-abuse-resistant-opioids. Accessed October 27, 2016.
• Wix K, Martin K. Daiichi Sankyo, Inc. and Inspirion Delivery Sciences LLC announce U.S. licensing agreement for MorphaBond™ formulated with SentryBond™ abuse-deterrent Technologydaiichisankyo.com/media_investors/media_relations/press_releases/detail/006545.html. Accessed October 25, 2016.
• Kaléo. Kaléo Announces 2017 U.S. Return Of Auvi-Q® (Epinephrine Injection, Usp) auto-injector for life-threatening allergic reactions. kaleopharma.com/kaleo-announces-2017-u-s-return-of-auvi-q-epinephrine-injection-usp-auto-injector-for-life-threatening-allergic-reactions. Accessed October 26, 2016.
• Burrows N, et al. Lynparza Phase III SOLO-2 trial shows significant progression-free survival benefit. astrazeneca.com/media-centre/press-releases/2016/lynparza-phase-iii-solo-2-trial-shows-significant-progression-free-survival-benefit-261020161.html. Accessed October 26, 2016.
• Livingston, S. Feds probing Express Scripts’ relationships with drugmakers, specialty pharmacies. modernhealthcare.com/article/20161026/NEWS/161029937. Accessed October 26, 2016.