WSJ: Pfizer recruiting for Lipitor OTC actual use study
NEW YORK — Pfizer is recruiting for a 1,200-patient actual use study to measure whether or not patients can appropriately self-select treating high cholesterol with the statin Lipitor, the Wall Street Journal reported on Sunday.
The trial is recruiting patients through more than 35 pharmacies and is expected to be completed by year-end.
The stumbling block for past statin switch applications has been the actual use study. And Pfizer may be facing an even steeper hill given that recommendations for statin drugs have become more complicated, the WSJ reported.
If approved for sale over-the-counter, Goldman Sachs estimates that a nonprescription Lipitor could generate more than $1 billion in annual sales. Presently, the best-selling OTC medicine is Pfizer’s Advil, which generated $490.9 million in sales across total U.S. multi-outlet for the 52 weeks ended Dec. 29, according to IRI data. That’s followed by Bayer’s Aleve ($364 million) and Procter & Gamble’s Prilosec OTC ($358.8 million).
CEO Ian Read shared with the WSJ that Pfizer is putting significant resources behind its over-the-counter effort and that the start of the clinical trial was "an important milestone."
Patients signing up for the trial are given an empty box featuring the proposed OTC labeling. In order to appropriately self-select, the patients must know their baseline level of bad cholesterol. In-store tests will be on hand for those patients who don’t know that number.
"Among other factors, the study will track what percentage of users comply with directions to get cholesterol levels checked again in six weeks, and whether consumers should continue to take the drug if it is working, or consult with a doctor if it isn’t," the WSJ reported.
FDA: Plan B generic equivalents can be sold without restrictions
SILVER SPRING, Md. — The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical’s Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties.
However, generic labeling will spell out indicated use for women 17 years of age and older considering that Teva has exclusivity on the indication for use for women under the age of 17, FDA decided.
"Restrictive labeling and point of sale restrictions of the type requested by Teva would be inconsistent with how exclusivity for specific populations is generally handled for ANDAs in other contexts," wrote FDA’s Kathleen Uhl, acting director of the Office of Generic Drugs at the Center for Drug Evaluation and Research.
"For example, when an innovator’s prescription product is granted exclusivity for a new indication, ANDAs approved for the non-protected conditions of use are not required to bear a statement specifically describing the limitations of the approval or to otherwise restrict the use of the generic drug. Similarly, multiple OTC products lack approval in one or more pediatric populations but no point of sale restrictions apply," she noted. "There is no scientific or regulatory reason to depart from that approach here."
PharmaSupply introduces NeedleBay insulin pen organizer
WEST PALM BEACH, Fla. — Pharma Supply earlier this week launched NeedleBay, a safe and easy method of organizing and dispensing insulin pen needles and medication.
NeedleBay provides a highly visible, unique and simple “proof of use” reminder, which eliminates the risk of missed, or excess injections and associated medications. NeedleBay has been specially designed in consultation with healthcare professionals and those with diabetes, to enable the user to deploy disposable pen needles safely and to avoid the risk of needle pick injuries.
NeedleBay allows the user to prepare in advance needles and medication for up to seven days using the NeedleBay daily modules, which can be preloaded at the beginning of the week. The NeedleBay module is compact and fits easily into a pocket or bag. The NeedleBay product line is available in multiple flexible pack sizes and colors.
NeedleBay will be available to consumers in March 2014 and will be supported with a national print and TV commercial campaign beginning in May 2014.