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Cipher Pharmaceuticals issued a response to the warning letter from the FDA regarding their pain reliever ConZip.
Earlier this week, Cipher Pharmaceuticals (TSX:CPH) issued a response to the US Food and Drug Administration (FDA) warning letter from late August.
The letter–made public on Tuesday (September 5) and officially sent by the Office of Prescription Drug Promotion within the FDA–claimed the detail aid for ConZip, a tramadol hydrochloride pain reliever made in capsules, was “false or misleading” due to the omission of relevant risk information related to its use.
“These violations are concerning from a public health perspective because they create a misleading impression about the safety and approved indication for ConZip,” the agency’s letter explained.
Opioid product didn’t warn addictive elements of pain relievers
The Regulatory Affairs Professionals Society reported the FDA took particular problem with the product marketing, claiming an “All Day Pain Relief” efficacy for ConZip without mentioning the risks and addictive effects of opioids.
“By omitting the risks associated with ConZip, including serious and potentially fatal risks, the detail aid fails to provide material information about the consequences that may result from the use of the drug,” the FDA wrote.
This warning, and demand for a correction, seems more relevant due to the FDA’s recent push against the damage caused by opioids and other pain relievers throughout the US. This move has been at the front of the FDA’s priorities since the appointment of commissioner Scott Gottlieb earlier this year.
Cipher was the recipient of this letter since they are the applicant for the new drug application (NDA). However their licensing partner Vertical Pharmaceuticals have the US license to market, sell and distribute ConZip.
Cipher replied to the letter by saying Vertical had already started correcting the issue by stopping ConZip’s distribution with the promotional material in question.
“[Vertical is] preparing a plan to collect and destroy the material, and commencing a corrective action communication to healthcare professionals,” Cipher added.
According to Cipher, ConZip amounted to approximately 2 percent of the total revenues for the company during the first half of their fiscal 2017.
No major repercussions to Cipher’s stock
Despite the news, it didn’t impact Cipher’s stock much during the trading week. At the close on Thursday (September 7), shares of Cipher were $5.22 and had experienced a 0.39 percent increase since the beginning of the trading week on Tuesday, due to Labour Day.
Over a year-to-date period, the company has seen a 5.1 percent increase to its stock.
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.
