Study Conducted by PEGUS Research Published in JAPhA.
A Self-Selection and Actual Use Trial conducted by PEGUS Research that investigated whether consumers can correctly select and use a long-acting immediate-release and extended-release 600 mg ibuprofen product was recently summarized in a manuscript and accepted for publication in the July/August edition of the Journal of the American Pharmacists Association. Sarah Farnsworth, who managed the study at PEGUS, was one of the authors of the publication. The study sponsor was Pfizer Consumer Healthcare.
We are pleased to have another example of prescription-to-over-the-counter switch research published in the literature, and hope that it can help contribute to the overall body of knowledge regarding critical consumer selection and use behavior dynamics. For additional information, see http://www.japha.org/article/S1544-3191(16)00161-8/abstract.
Sarah Farnsworth Receives Award
One of our own has just been recognized among the 2016 “30 Women to Watch” in Utah. Dr. Sarah Farnsworth, Vice President and shareholder at PEGUS Research, is one recipient of this honor presented by Utah Business Magazine. The 2016 “30 Women to Watch” celebrates Utah’s most successful and influential women as selected by their peers. To see the short video presentation highlighting Sarah’s accomplishment, please see: http://www.utahbusiness.com/sarah-j-farnsworth-30-women-to-watch/. We congratulate Sarah!
Human Factors Research
For years the FDA has requested device and Rx manufacturers to conduct human factor studies, sometimes also referred to a usability studies. In contrast to label comprehension studies, which assess the extent to which consumers understand the information on drug product labeling (see FDA LCS Guidance here), the intent of human factors research is to evaluate the user interface of a product, or in other words the ability of users to follow and actually perform the needed instructions in a way that eliminates or mitigates potential use-related hazards. In February of this year, the FDA issued draft guidance on how to conduct these studies for combination products (e.g. products comprised of both a drug and a device).
In the last few years the Division of Nonprescription Drug Products (DNDP) has begun to make more requests of OTC sponsors to conduct human factors studies when a proposed OTC product requires consumers to do something more than just take a pill (for example, prime a device prior to administering a dose, or correctly spray the product into the nose or mouth in the case of inhalers).
Most clients know the work PEGUS Research does in support of Rx-to-OTC switch and OTC brand line extension programs (including Drug Facts Label development and the design and conduct of label comprehension, self-selection and actual use studies). However, some may not yet know PEGUS also conducts human factors studies for OTC combination products to address specific research needs and requests from the Agency. We have supported a number of human factors studies for OTC clients. If you have questions about ways PEGUS can assist with human factors research, please contact us at 801-487-9899 or visit our website at http://www.pegus.com/human-factors-research.html.
New Executive Team Members
PEGUS is pleased to announce the addition of 3 key leaders to our newly re-organized Executive Team:
- Kimberly Anderson, MPH will now serve as Vice President of Clinical Operations
- Sarah Farnsworth, PhD will serve as Vice President of Scientific Affairs
- Erin Cunningham will serve as Vice President of Finance and Business Operations
These are changes envisioned for years at PEGUS, and we welcome the new group of incredibly capable leaders to our PEGUS Executive Team. These new assignments highlight the evolving depth, experience and scientific and operational ability that characterize PEGUS. In addition, Katie Callaway and Brandon Henrie, MS will now serve as Directors of Clinical Operations.
For more information about PEGUS leadership (including other continuing members of the Executive Team), see the “Our Team” link above. To find out more regarding ways our research services can enhance your programs, contact David McCammon (801-990-6121, email@example.com) or Clark Richardson (801-990-6126, firstname.lastname@example.org).
Clark Richardson Participates in Annual CHPA Regulatory, Scientific and Quality Conference
Clark Richardson, President at PEGUS Research, participated in the May 14-15, 2015 CHPA RSQ Conference in a session titled, “Innovative Methods for Understanding Consumer Behavior.” The PEGUS presentation focused on innovations in label comprehension testing, including ways to sample more effectively from the right populations and better engage consumers with enhanced tools and technologies. A copy of Clark’s presentation can be found at URL:
http://www.chpa.org/2015RSA1.aspx (see page 14).
In a presentation on a related topic, CDER’s James Stansbury shared important insights regarding FDA’s newest thinking on “Design and Innovations in Consumer Research” (see URL: http://www.chpa.org/2015RSA3Stansbury.aspx), adding emphasis to the utility of creative thinking and improved methods.
PEGUS Awarded New Modified Risk Tobacco Consulting and Research Program
A new business segment has been initiated due to modified risk tobacco products coming under FDA regulatory authority and review. PEGUS has experience in addressing FDA requirements and conducting needed studies to answer critical regulatory questions. The studies for these products appear likely to follow a consumer research program model similar to the one typically followed for a traditional OTC-switch NDA, including label comprehension, self-selection, and actual use.
Our team of scientists and technical study staff can help with a wide range of unusual questions pertaining to consumer health.
FDA Announces OTC Approval of Listerine® Sensitivity Defense™
PEGUS Research congratulates our client Johnson and Johnson on the 29 January 2015 OTC approval of Listerine® Sensitivity Defense™ Mouthrinse for relief from tooth sensitivity (see URL: http://www.accessdata.fda.gov/cdrh_docs/pdf14/k143155.pdf).
We were honored to be part of this effort in assisting to refine the package information and conduct pilot and pivotal label comprehension studies. It is always with satisfaction that we see such efforts resulting in approval.
This follows earlier successful approvals we supported for Oxytrol for Women (January 2013) and Nasacort (October 2013). We expect additional successes in the near future as our clients submit NDAs in 2015 and 2016. To learn more about how we can support your device or medication switch efforts, please contact Dave McCammon (801-990-6122) or Clark Richardson (801-990-6126).
FDA Advisory Committees Consider Current Data Regarding CV Risk for NSAIDS
On February 10-11, 2014, the Arthritis and Drug Safety and Risk Management Advisory Committees jointly met to consider the current body of evidence regarding the relationship between use of COX-2 selective and non-selective NSAIDs and important CV risks. Key staff from PEGUS were in attendance. The Committees ultimately voted 16 to 9 against making labeling changes for NSAIDs based on current data available.
Meeting information and materials can be found here:
FDA Announces Joint Non-Prescription / Pulmonary Allergy Advisory Committee Meeting
On February 26, 2014 the Non-Prescription Drugs and Pulmonary Allergy Drug Advisory Committees will convene a joint meeting to consider an application for over-the-counter marketing of epinephrine inhalation aerosol (Primatene HFA), for temporary relief of mild symptoms of intermittent asthma. Note that key staff from PEGUS Research will present/participate in this meeting.
More information about the meeting can be found here:
Canada Rx-to-OTC Experience and Services
PEGUS Research has recent experience navigating the Rx-to-OTC process with Health Canada. As part of interactions in 2013 with sponsors and Health Canada, PEGUS can provide insights and understanding regarding how best to develop the OTC package information and then test it in a label comprehension study specifically designed for a Canadian environment.
For more information about switching medications in Canada, see:
Contact Us to request more information about our services and expertise in this area.
PEGUS Research Involvement in Creative Packing Information Approach
In addition to the various single-ingredient acetaminophen (APAP) products, there are many combination products on the market containing APAP, often intended for the same indications. This presents an increased risk of overdose when consumers fail to recognize that the combination product contains the same drug they may have already taken to relieve their symptoms. As part of its responsible product stewardship, Johnson & Johnson undertook an extensive program of research to learn how to educate and alert consumers about this risk. That research culminated in the decision by J&J to mark their product caps with a distinctive message about the presence of APAP in the product (see http://www.tylenol.com/news-sub-cap).
PEGUS Research was pleased to be a member of the team that conducted the research and evaluated the various alternative solutions. We congratulate J&J on this important public health initiative.
Final FDA Self-Selection Guidance
In April 2013, FDA issued its final guidance titled "Self-Selection Studies for Nonprescription Drug Products," which is intended to provide recommendations to those involved in developing and conducting self-selection studies to support an application for nonprescription drug products.
Oxytrol for Women Approval
On January 25, 2013, the FDA approved Oxytrol for the treatment of overactive bladder in women. We congratulate Merck on their successful switch to OTC status. We appreciate the opportunity PEGUS Research had to assist from the start in consulting and then conducting a Self-Selection Study and the Pivotal Actual Use Trial. We express our appreciation to our pharmacy study teams that supported the research efforts. It is exciting to have been part of the effort that gained this approval.
Recent FDA Audits
PEGUS Research and its pharmacy sites recently underwent a series of audits by the FDA. Due to the outstanding work by our team, their keen attention to detail, and the quality of our investigators, the audits were successfully concluded with only minor findings and no Form 483 issued. Given the challenging nature of the studies we conduct, we are extremely pleased with these results.
David Bradford's Article
When Dr. David Bradford, Sr. Vice President and co-founder of PEGUS, was recently invited to write an article for the Tan Sheet, the selected topic was an exposition of key differences between efficacy and OTC actual use trials. Key points include:
Efficacy trials are indispensable for evaluating whether a new drug has a therapeutic effect and estimating the size of that effect. The overarching objective of the design and conduct of an experimental trial is to eliminate any alternative explanations for post-treatment differences among the treatment groups, so that the only credible explanation is the variation in the active ingredient.
Focus Group Facility
We recently completed all the preparations and inaugurated our brand new, well-equipped in-house focus group facility, where qualitative label development research can be conducted.
The facility includes a comfortable focus-group room for interviewing or open discussion, a room from which clients can unobtrusively observe, and an informal lounge with video and audit feeds. Video and audio can also be recorded for future playback, and Internet streaming capabilities will be added soon.
Information gathered in focus groups allows sponsoring companies to develop consumer-oriented label information, pretest questionnaires and other stimuli, and ultimately to make more informed decisions about moving the development program forward. This new focus group facility is just one of many services offered to our valued clients.
© PEGUS Research, Inc. 2016. Salt Lake City, Utah, United States. Tous droits réservés / All rights reserved.