Pulse Newsletter
Your source for the latest industry trends and drug information news.
Volume 1 | Issue 4
March 15, 2019
Contributors:
Chief Author: Kevin Lavery, PharmD
Editor: Dana Ranallo, PharmD
Clinical Update
FDA plans new steps to address opioid crisis
At the end of February, the FDA Commissioner, Scott Gottlieb, outlined the steps the agency is taking in 2019 to fight the opioid epidemic. Noting that addressing the crisis is one of the agency’s top public health priorities, Gottlieb explained that the agency is “aggressively and compassionately pursuing new efforts to address the tragedy” through several strategies including:
- Mandating short-duration (unit dose) packaging for select solid opioid oral dosage forms
- Advancing development of safe and effective medication-assisted treatment (MAT)
- Expanding availability of naloxone, an opioid reversal agent
- Issuing guidance outlining appropriate clinical trial approaches for development of non-opioids
- Promoting development of abuse-deterrent opioid formulations
- Strengthening enforcement against illicit opioids
Safety First
FDA adds Boxed Warning to gout medication
The FDA is adding a Boxed Warning to Uloric® (febuxostat) after noting there may be an increased risk of cardiovascular death and death from all causes in patients being treated with this medication when compared to another gout medication, allopurinol. The average wholesale price for a 30-day supply of allopurinol ranges from about $28.99 to $55.41 compared to a 30-day supply of Uloric®, which averages about $396.04. In addition to the Boxed Warning, the FDA is also limiting the use of Uloric® to patients who are not treated effectively or cannot tolerate allopurinol. Gout is a chronic condition that occurs when a natural substance in the body called uric acid accumulates and causes sudden attacks of redness, swelling and/or pain in the joints. Gout affects approximately 8.3 million adults in the U.S.
From the Industry
Google joins the fight against opioid epidemic by providing drug disposal locations
Google Maps users will be able to use the phone app to enter search terms such as “drug drop off near me” or “medication disposal near me” and find disposal spots at local pharmacies, hospitals, and government buildings. To maximize the program’s reach, Google has partnered with DEA, HHS, CVS Health, Walgreens, and state governments The initiative is expected to launch with 3,500 locations nationwide ahead of this year’s National Prescription Drug Take Back Day held in April.
FDA Approvals
Recent FDA Approvals
3 new medications to treat blood related conditions
Vancomycin (vancomycin)
Premixed injection for the treatment and prevention of certain serious bacterial infections [2/15/19 – Priority Review – XELLIA PHARMS APS]
Lotemax® SM (loteprednol etabonate)
Topical gel for the treatment of postoperative inflammation and pain following eye surgery [2/22/19 – BAUSCH AND LOMB INC]
Adhansia™ XR (methylphenidate hydrochloride)
Extended-release capsules for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) for patients six years and older [2/27/19 – PURDUE PHARMA LP]
New Generics
New Generics Entering the Marketplace
cyclobenzaprine (Amrix®)
Indication: Muscle Spasm
Dosage Form/Strength: 15MG ER, 30MG ER capsule
Average Wholesale Price (AWP): Generic = $1,358/30 day supply (DS) | Brand = $1,540/30 day supply (DS)
minocycline (Solodyn®)
Indication: Acne
Dosage Form/Strength: 105MG ER tablet
Average Wholesale Price (AWP): Generic = $1,315/30 day supply (DS) | Brand = $1,462/30 day supply (DS)