28 Jul Opiates for Depression? Are You Serious?
Historically, Egyptians used a product of poppies for melancholia. Recently, modern medicine has revisited this theory to see if opiates could have a positive effect for treatment resistant depression. The controversy of opiates and their role in easing the symptoms of depression has been a topic of debate for quite a while now. Treating depression, a chronic illness, with an opiate, could cause dependency on the drug whilst treating the depression. The Institute for Advanced Medical Research at Mercer University is currently conducting a clinical trial of ALKS 5461, an opioid containing investigational drug, for treatment refractory Major Depressive Disorder (MDD).
What is ALKS 5461?
Atypical antipsychotics are currently the only approved adjunct therapy for treatment refractory MDD, and often patients discontinue this therapy due to their side effects, such as serious toxicity and tardive dyskinesia. ALKS 5461 is a once daily sublingually administered drug with active ingredients buprenorphine (BUP) and samidorphan (SAM), that can be used after treatment for MDD has been unsuccessful by serotonin selective receptor inhibitor (SSRI) drugs, such as Citalopram (Celexa) and Fluoxetine (Prozac). BUP is a US DEA Schedule III narcotic and is currently FDA-approved for chronic pain and opioid dependence. SAM is a US DEA Schedule II controlled substance and is not FDA-approved.
Why ALKS 5461?
There is data to support the rationale for ALKS 5461’s use as an adjunct therapy for treatment refractory depression, clinical studies have shown that the μ–opioid receptor partial agonist, BUP, increases opioid tone in impaired brain regions of depression patients who had an inadequate response to antidepressant treatment. However, the risk of abuse, dependence and diversion had impeded its use as a general treatment option for depression. The potent μ-opioid receptor antagonist, SAM, was added to BUP to decrease the opioid tone in upregulated areas of the brain, and thus reduce risk of abuse, dependence and diversion. This unique combination drug may therefore allow for better modulation of the opioid system, and thus help treat depression. So far, efficacy has been observed in phase 2 trials and is currently in phase 3 trials. Furthermore, FDA has granted ALKS 5461’s sponsor, Alkermes, Fast Track status to its review schedule.
In addition to this trial, there are several more being investigated at the Institute for Advanced Medical Research at Mercer University. For students that are interested in knowing more about these clinical trials, the institute provides you with an opportunity to visit the clinic and learn about the world of clinical research. You will get to shadow the investigational site personnel, learn of the different phases of clinical trials, obtain in-depth knowledge about possible future therapies for inadequately treated conditions, and also gain insight on career options in clinical research. Give us a call at 770-817-9200 for more information.