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Feeling Depressed? ALKS 5461: The Fix of the Future?

Feeling Depressed?

“Okay, Bill, I’ve been feeling depressed. Now, I don’t expect a new and exciting antidepressant to hit pharmacy shelves tomorrow, but is anything in the pipeline?”

I ran a poll on chipur not long ago posing this question: If you had to choose just one method of treatment for your mood or anxiety disorder, what would it be? The choices were meds, psychotherapy, and spirituality. Meds led the pack, receiving 35% of the vote.

Being an emotional/mental health clinician – more importantly, an anxiety/mood disorder vet – I’ve never had an issue with someone who endures a mood or anxiety disorder using certain psychotropic medications. ‘Course, psychotherapy and spirituality are super-important recovery tools that need to be utilized if one elects to go the meds route.

I’m frequently asked if I know of any new developments in the arena of medications for the mood and anxiety disorders. And so I try to stay up-to-date.

Recently I found something I believe you’ll find interesting and encouraging.

Alkermes Pharmaceuticals (Dubin, Ireland) has come up with an investigational drug they’re calling ALKS 5461. Sounds so “hush-hush,” don’t you think?

Perhaps this is why. If all goes according to plan ALKS 5461 may provide depression and anxiety relief that rivals using heroine or, say, OxyContin. And how ’bout this? ALKS 5461 is touted to be non-addictive and non-abusable.

Incidentally, Alkermes Pharmaceuticals is the same corporation that developed and markets Vivitrol. It’s the injectable form of naltrexone, which can remove the “buzz-factor” from using alcohol and other substances.

Do I have your attention?

Feeling depressed? So what is ALKS 5461?

Well, ALKS 5461 is actually a two molecule combo. Molecule number one is buprenorphine. Heard of it? Wouldn’t be surprised. It’s the semi-synthetic opioid that’s used to treat opioid addiction, as well as moderate acute and chronic pain in non-opioid-tolerant individuals.

It’s an active ingredient in the medications Suboxone (with naloxone) and the transdermal patch Butrans. By the way, buprenorphine’s analgesic effect is some 25 to 40 times more potent than morphine.

Okay, so wait a minute – “I’m going to be taking something that’s powerfully addictive for my depression or anxiety?” Yep! But let’s not forget about ALKS 5461’s second molecule – ALKS 33.

ALKS 33 acts as a barrier to the binding of buprenorphine to the receptors that make us feel euphoric. It’s those very receptors that are responsible for the craving of opiates.

Do you see how ALKS 5461 is put together? Part of it’s about the “buzz” generated by buprenorphine. And the checks-and-balances are provided by ALKS 33.

So why is everyone getting so excited about ALKS 5461 – an investigational drug? Well, it brought quick relief to all 32 major depressive disordered participants in a blind, placebo controlled study (participants didn’t know if they were taking ALKS 5461 or the infamous sugar-pill).

What’s more, all 32 participants had zippo luck with the antidepressants fluoxetine (Prozac) or venlafaxine (Effexor).

It seems we’ve established the fact that ALKS 5461 is a potentially game-changing drug for the treatment of depression and anxiety. Okay, great – how long before we see it on pharmacy shelves?

Fact is, we may not. I mean, Alkermes could pull the plug on it anytime if it’s not living up to expectations during the FDA approval process. For now, however, ALKS 5461 is in Phase 2 clinical trials. Um, but it could take seven years before it’s approved.

But take heart – the FDA has Fast Track, Accelerated Approval, and Priority Review approaches that are intended to make therapeutically important drugs available earlier. So if ALKS 5461 is really “all that,” perhaps we won’t have to wait seven years to give it a go.

Now, you may be thinking, “Geez, thanks Bill. You get me all worked-up over a potentially game-changing med and it could be seven years away – if it hits the market at all.”

Well, you may have me there. However, you need to not only know the mood and anxiety disorder relief meds in the pipeline – you need to know creative efforts are being made to lend a hand to those enduring depression, anxiety, or bipolar disorder.

Feeling depressed? ALKS 5461 may in fact be the fix of the future. And now you know.

image credit gaspirtz.com

Would you like to read more chipur articles about meds, supplements, and devices used in the treatment of the mood and anxiety disorders? Please – have at it! Feeling depressed, anxious, or manic? Check-out these chipur Feelin’ Better articles.

Bill White Hi! I’m Bill White, founder and producer of Chipur. Are you looking for help? The miles are irrelevant. Visit my Coaching|Mentoring page.

  • Sarah

    I suffer with Major Depression, when is this medication going to be available? Can I be a subject to try this medication?

    • http://chipur.com chipur

      Hi Sarah!
      Thank you for visiting Chipur and participating in the discussion. Unfortunately, I’m thinking GLYX-13, if it makes it through clincial trials, may not be on pharmacy shelves for a couple of years yet. It’s always difficult to write these pieces because, though it’s hopeful and important information, there is a significant time-lag to reality. Renee provided a link to clinicaltrials.gov. If you hit the home page, type in GLYX-13 in Search for Studies. You’ll see there are several, and they’re recruiting.

      Again, thanks for checking-in.

  • Stevo1035

    I see this is now in phase 3 trials. Given that it was granted fast track status, and that they anticipate completion of phase 3 by the end of this year, is there an estimated time we can expect for it to be approved? Assuming it passes phase 3 of course. I don’t know anything about fast track status as far as how much more quickly the FDA moves to stamp approval or disapproval. Thank you in advance.

    • http://chipur.com chipur

      Hey Stevo!

      My understanding is after Phase 3 – and drug proves to be safe and effective – the drug company files New Drug Application (NDA)/ Biologics License Application (BLA). If approval comes, it’s typically 1-2 years after these applications have been filed. The fast track designation? Drug can receive Priority Review. How much time does that knock-off the drug hitting shelves? I just don’t know. Further, my searching didn’t reveal any info as to on-the-shelves date for ALKS 5461..

      Sure appreciate your visit and comment. Wish I could have come up with something more definitive…


      • Stevo1035

        Thank you so much for your reply Bill. I have bad depression and OCD/anxiety and I have become treatment resistant to the SSRI’s and SNRI’s, so I’m really hoping something novel comes available sooner than later.

      • http://chipur.com/ Chipur

        Well, you’re welcome, Stevo. Wish I had more to offer. This one is still a ways off, but it’s hopeful stuff chipur.com/i-feel-depressed-so-whats-in-the-relief-pipeline-lets-chat-glyx-13/


  • Doug Gerard

    you say it rivals the use of “heroine”…are you referring to a woman of distinguished courage and ability?

    • http://chipur.com/ Chipur

      Got the drop on me there, Tex. But it is an interesting angle…

  • Big Ben

    While the clinical trials take years people who suffer from “treatment resistant” depression commit suicide on a daily basis. The ones who survive do what it takes regardless if the government approves.

    • http://chipur.com/ Chipur

      Appreciate your visit and comment, Big Ben. Yeah, no doubt, an incredibly frustrating set of circumstances. I don’t understand why the majority don’t (want to) attach the concept of mortality rate to depression – just like cancer, etc. Why are those enduring emotional/mental situations left to their own devices? Hmmm.
      Again, thanks for stopping-by. Hope you continue to…