trending Market Intelligence /marketintelligence/en/news-insights/trending/xqC1q0YDIQJ-bKLKK7kBgw2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

Thank you for your interest in S&P Global Market Intelligence! We noticed you've identified yourself as a student. Through existing partnerships with academic institutions around the globe, it's likely you already have access to our resources. Please contact your professors, library, or administrative staff to receive your student login.

At this time we are unable to offer free trials or product demonstrations directly to students. If you discover that our solutions are not available to you, we encourage you to advocate at your university for a best-in-class learning experience that will help you long after you've completed your degree. We apologize for any inconvenience this may cause.

In This List

Alkermes issued US FDA warning letter on 'misleading' Vivitrol advertisements

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help


Alkermes issued US FDA warning letter on 'misleading' Vivitrol advertisements

Alkermes PLC has received a warning letter from the U.S. Food and Drug Administration regarding its print advertisements for opioid dependence treatment Vivitrol, which did not disclose the most serious risks associated with taking the drug.

The FDA posted its warning letter Dec. 11, stating that Alkermes' advertisements for Vivitrol included the injection drug's benefits, but not the risks of vulnerability to opioid overdose. The FDA also said the Vivitrol advertisements omitted information about other common adverse events, such as injection site reactions.

"The print ad is false or misleading because it omits important risk information associated with the use of Vivitrol," the FDA wrote in the letter. "Thus, the print ad misbrands Vivitrol within the meaning of the Federal Food, Drug and Cosmetic Act."

Alkermes is expected to respond to the letter by Dec. 16, according to the FDA's press release. The regulator requested that the Dublin-based company immediately halt its Vivitrol advertisements containing misleading information, and come up with a plan to disseminate accurate information about Vivitrol to consumers who may have received the previous advertisements.

Alkermes' advertising violations are "serious," the FDA said.

Vivitrol is an extended-release injection formulation of naltrexone, a commonly used substance to prevent relapse of opioid dependence. Vivitrol works by blocking the effects of opioid drugs, which can result in a higher response rate to a lower dose of opioids. If a patient takes opioids after taking Vivitrol, an overdose could occur, the FDA said.

"This violation is concerning from a public health perspective because it creates a misleading impression regarding the overall safety of Vivitrol," the agency wrote in the letter.

The opioid crisis is estimated to kill about 130 people per day in the U.S.