Vivus submits sNDA in support of a shorter efficacy window for its ED medicine Stendra
MOUNTAIN VIEW, Calif. — Vivus and Auxilium Pharmaceuticals on Tuesday announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction."
The PDUFA date for the supplemental filing is Sept. 20, 2014.
Vivus had previously announced positive results from this multicenter, placebo-controlled study designed to assess the efficacy of two dosage strengths of Stendra approximately 15 minutes after dosing.
In the 440-patient study conducted at 30 sites in the U.S., Stendra patients achieved statistically significant improvement versus placebo in the mean proportion of attempts that resulted in erections sufficient for successful intercourse as early as 10 minutes for the 200 mg dose and 12 minutes for the 100 mg dose following administration.
The currently approved prescribing information recommends administration approximately 30 minutes before sexual activity.
IMS Institute report: Half of all pharmaceutical manufacturers actively using social media
PARSIPPANY, N.J. — With the role of social media rapidly expanding, nearly half of pharmaceutical manufacturers are now actively using this channel to engage with patients on healthcare-related topics, according to a new report released Tuesday by the IMS Institute for Healthcare Informatics.
“Increasingly, patients are turning to social media as an essential forum for obtaining and sharing information related to their health,” Murray Aitken, executive director of the IMS Institute for Healthcare Informatics, said. “This trend only heightens the need for relevant, accurate content that can be accessed and used throughout the patient journey. Healthcare professionals, regulators and pharmaceutical manufacturers all need to overcome their reticence and acknowledge the vital role that they can and should play in contributing to the healthcare conversation.”
To examine the current state of online consumer behaviors in Facebook, Twitter and YouTube, researchers developed the IMS Health Social Media Engagement Index. The proprietary Index assesses reach, based on the total number of individuals exposed to a message via likes, shares or re-tweets; relevance, the degree that content is found useful and shared across social networks; and relationship, the level of direct interaction around specific content.
As many as 23 of the top 50 global pharmaceutical manufacturers have some level of healthcare-related social media engagement. Of the companies reviewed by the IMS Institute, the top-ranked organization based on the IMS Health Social Media Engagement Index is Johnson & Johnson, with an overall score of 70. Other companies ranked in the top 10 on the Index have scores ranging from 25 to nine. Mid-sized organizations, including Novo Nordisk, Boehringer Ingelheim and UCB, are utilizing social media as effectively, or more effectively, than the largest pharmaceutical manufacturers. The overall level of engagement between pharmaceutical companies and patients has steadily increased during the past year as more organizations become active in this area.
The study – Engaging Patients through Social Media – found that only 10 companies utilize all three of these major social networking services for healthcare topics. Many companies are using social media primarily as a unilateral broadcasting channel to physicians and patients, with limited interaction or fostering of discussion. Smaller manufacturers with narrower therapeutic focuses and consumer health companies typically have the highest levels of social media patient engagement.
Regulatory agencies are active in social media even as manufacturers await final guidance on requirements. Regulators increasingly are utilizing social media channels to connect to a wider healthcare audience. The Food & Drug Administration, which has a particularly strong Facebook presence, ranks highly on social media engagement and has a higher relationship score on the IMS Health Index than any pharmaceutical company. The European Medicines Agency operates its Twitter feed with one of the highest reach index scores, second only to the FDA. The direct involvement of regulators into healthcare discussions online indicates their understanding of the value of a strong social media presence. The FDA has committed to deliver its final regulatory guidance on social media usage by the middle of 2014, providing the industry with more confidence in its social media participation.
Wikipedia is the single leading source of medical information for patients and healthcare professionals. The top 100 English Wikipedia pages for healthcare topics were accessed, on average, 1.9 million times during the past year. Rarer diseases, which often have fewer available information sources and are less understood by patients and clinicians, show a higher frequency of visits than many more common diseases. In an assessment of 50 major disease-specific Wikipedia articles, the Institute found a strong correlation between page views and medicine use, with online information-gathering occurring throughout the patient journey. Content incorporated or changed on healthcare-related Wikipedia pages is subject to constant change, often overseen by informal or formal working groups. An assessment of Wikipedia disease articles indicates that at least half of the changes made are related to patient-relevant information.
Social media engagement lags significantly within the population segment that uses healthcare services the most. Age is one of a few differentiating factors in the use of social networking sites, where utilization is less dependent on gender, education, income or other forms of social advantage. Younger people tend to conduct online investigations before the start of therapy, as measured by prescriptions or sales of medications. By contrast, patients age 50 or older tend to begin their treatments prior to seeking information online. The difference of utilization by age groups will diminish as “digital natives” increase their involvement and influence professionally and privately within their networks.
The full version of the report, including a detailed description of the methodology, is available at TheIMSInstitute.org. The study was produced independently as a public service, without industry or government funding.
SIUE School of Pharmacy appoints Lubsch to lead Pediatric Pharmacy initiative
EDWARDSVILLE, Ill. — The Southern Illinois University Edwardsville School of Pharmacy’s Lisa Lubsch has been appointed to lead the Pediatric Pharmacy Advocacy Group-University initiative.
SIUE’s Lisa Lubsch, clinical associate professor of pharmacy practice in the School of Pharmacy, with a patient.
As part of her role beginning in spring 2015, Lubsch will direct section leaders from 15 areas of expertise in the field of pediatric pharmacy. “I have had the pleasure and honor working my way through the ranks of the Pediatric Pharmacy Advocacy Group, which has been an integral part of my professional development,” stated Lubsch, a clinical associate professor of pharmacy practice. “I am thrilled to be developing the first programs of the PPAG-U and to see my pediatric colleagues become recognized by board certification in our specialty area as they improve the care of children across the country.”
The Pediatric Pharmacy Advocacy Group helps prepare for pediatric board certification through educational opportunities and programming. The newly created PPAG-U will be a central hub for educational courses, conferences, programs and information designed to support the educational goals of pediatric pharmacists.
“It is commendable that Dr. Lubsch has been recognized to head the PPAG-U initiative,” added Gireesh Gupchup, dean of the SIUE School of Pharmacy. “It is an indication that she is recognized nationally as a thought leader in the area of pediatric pharmacy.”