File this under “What were they thinking?”
At a time when selling opioid painkillers is fraught with challenges, two companies committed an unnecessary blunder. The US Food and Drug Administration decided that Pain Therapeutics and Durect were jointly touting an experimental drug on their web sites in a way that appeared so misleading that the agency issued a rare letter to criticize their marketing practices.
According to the Sept. 8 letter, which the FDA posted on its website this week, the companies made statements that consumers might construe to mean the drug, Remoxy ER, is already approved for use. The agency pointed to certain language on the company websites — such as “long-acting” and “tamper-resistant” — that gave the impression these were “established facts” pertaining to an approved drug.
Sounds like this guy who wrote this nonsense is “short” the position.
I happen to be a investor of PTIE and it CLEARLY STATES that remoxy er was NOT FDA approved and even has given the date in which it was supposed to be reviewed by the FDA! It does state that it’s abuse deterrent but those are the facts stated on every website, which have been alot, that I looked at before investing. The majority of the deaths if you look at the statistics most deaths are happening because it’s being taken by abusive and other ways other than what is prescribed by the doctor! So why would you NOT explain that it’s made without abuse deterrent to an investor? Sounds like other pharma companies wanting to keep things the way they are and not make the medication to where it can’t be crushed or injected. These are dirty back door tricks used to keep all the profits going to the same companies. Besides the only thing I read that was keeping it from being passed was the manufacturing capabilities. Make sure you get your information from as many sources as possible before casting stones. And why would you NOT want it to have an abuse deterrent in it? They should all be made that way to keep people from abusing the meds. Read Yahoo finance and you’ll see that it CLEARLY states it is still under review. Common sense and research ladies and gentlemen!
May I observe this post was based upon the FDA Warning Letter and not investment research? Full disclosure – I am not an investor in any pharma companies.
Ed, I wouldn’t expect a response from the companies. Durect has already corrected the information on their website. Just another example of our industry doing the right thing by putting patients before profits.
Pharmavet1, I’m the one who is at a wedding at the moment but it does seem that you are the one ‘who has been drinking?’ Apologies for any typos…
Observer, I have been drinking my nightly concoction. Its called Pharma Kool Aid with a splash of humility.
Given the pending decision date, and the date of this letter, may I simply observe – “Oh, the pain of it!”
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