Addictive opioid-based antidepressant back in FDA pipeline

Will this med create a new wave of opioid addicts?

If there’s anything we don’t need, it’s another antidepressant.

And if there’s anything we absolutely, positively don’t need, it’s another addictive opioid med.

So, obviously, the very last thing we need is an antidepressant/opioid combo.

Yet the FDA just did an about-face on a new drug application it recently turned down – a change of mind that has put a risky, addictive med back on the soon-to-be-approved track.

It’s a Big Pharma hat trick to put another opioid on the market under the guise of an antidepressant.

But as one expert warns, those who take this newly approved drug combo may have never taken an opioid before in their lives – and they’re just seeking relief from depression that hasn’t been helped by other treatments.

There are ways, however, to effectively treat depression without putting yourself in danger of a life-threatening opioid addiction.

The next opioid crisis?

Known by code name ALKS 5461, the new concoction from drugmaker Alkermes is a mix of a drug named samidorphan and an opioid called buprenorphine. While samidorphan is brand-new, buprenorphine is already a blockbuster that’s been marketed as a therapy to treat addiction to other opioids.

Alkermes has been trying to shove ALKS 5461 through the FDA’s door since January. And guess what? At first, the FDA said NO. When was the last time that happened?

I didn’t think the FDA had ever met a drug it didn’t like!

Whatever the reason, it was a win for common sense. Unfortunately, the FDA rescinded its rejection just two weeks later.

And all it took to change the agency’s mind was a friendly chat with the drugmaker. Now, we’re hearing that the rebuff was simply the result of a “misunderstanding,” and according to the Alkermes CEO, it took a while to get the FDA to see things clearly.

That’s right – just show the FDA which side its bread is buttered on, and the agency will approve yet another use for a highly addictive drug that’s just as deadly and likely to be abused as other opioids.

Unbelievable!

As I shared with you last week, the idea is that buprenorphine can reduce opioid cravings and help wean someone off risky drugs like heroin or OxyContin by limiting the opioid dosage so users don’t get “high.”

That claim, however, makes about as much sense as the idea that the Earth is flat.

Even taken at a small doses, buprenorphine is highly addictive all on its own. And for someone who’s not weaning off harder drugs, it’s quite possible that it will open the door to something that packs a stronger punch.

Instead of helping people who are hooked get off of these dangerous meds, an antidepressant like this could actually be setting the stage for a new wave of addicts!

The current opioid crisis is so bad that in Ohio, where well over 4,000 residents died because of an overdose in 2016 alone, tots in kindergarten are now being given drug-abuse education classes along with learning how to tie their shoes.

ALKS 5461 could be approved within the year. I don’t know what tongue-twisting new name they’re going to give it, but I’ll be following this closely, and I’ll let you know as soon as I hear something.

In the meantime, if you’ve been suffering from depression — especially if you’ve been taking prescription drugs that don’t seem to be working — there could well be other factors at work that can be remedied without having to rely on these kinds of risky drugs.

HSI advisory panel member Dr. Mark Stengler has found that depression can often result from nutritional or hormonal imbalances, and finding a doctor who will take the time to uncover the real reason for your depression – instead of just giving you a knee-jerk Rx for an antidepressant – could be the answer that you’ve been searching for.

“Plot twist: FDA pivots on Alkermes’ depression drug” Amirah Al Idrus, April 16, 2018, FierceBiotech, fiercebiotech.com