“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.