Alar Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focused on developing long-acting injectables (LAIs) for central nervous system disorders, announces positive interim results from the single-ascending-dose study of ALA-1000. A 3-month buprenorphine released injectable designed to be dosed subcutaneously for treating opioid use disorder (OUD).

The Buprenorphine release from the ALA-1000 single injection lasts over 12 weeks with effective concentrations, showing low initial burst without dose dumping effect and good safety and tolerability, including local skin irritation and injection pain severity.

Opioid dependency: A world health issue

The world-wide opioid epidemic is a documented public health crisis. Treatments for opioid abuse currently rely on Buprenorphine, Methadone, and Naltrexone as Medication-assisted treatment (MAT). However, patients' need to make frequent trips to clinics for oral MAT treatment often leads to relapses or further substance abuse through the switching of one habit for another.

While the industry continues to provide improved public awareness in workplaces, emergency departments, and the correctional system, more needs to be done to solve recurring opioid and opioid treatment abuse. The development of LAIs is considered an effective way to meet patients' needs and reduce opioid dependency.

In a breakthrough, Alar Pharmaceuticals Inc. presents ALA-1000, the first three-month released Buprenorphine injection as a potential solution to these issues. 

ALA-1000: a pathway to reduced dependency.

ALA-1000 is a long-lasting biodegradable injectable administered subcutaneously once every three months allowing patients to keep their addiction at bay by reducing the need for daily treatment to four times per year. It is of particular benefit to patients treated and stabilized with oral medications or other, shorter-interval Buprenorphine LAIs. 

Furthermore, the dosage reduction also removes the requirement for frequent – and often supervised – visits to the clinic. Reducing the potential financial, time, and personal burden on individuals to travel daily to receive treatment for a dependency subject to significant social stigma. Thus, LAIs have the potential to reduce the risk of relapse and improve compliance.

"Due to several technological barriers, it is hard to develop formulations capable of lasting over a month. This is why only a few pharmaceutical companies are developing long-acting medications," says Charles Lin, Founder and Chairman of Alar Pharmaceuticals. "Alar is the sole developer of the three-month released Buprenorphine. We hope more companies can devote their resources and work together with us to address this public health crisis."

Yung-Shun Wen, Ph.D., CEO of Alar Pharmaceuticals, firmly believes that ALA-1000 will be a better choice for patients and physicians. "The three-month released injection can not only alleviate concerns from daily oral medications but also remove barriers to treatment due to the COVID-19 pandemic such as prevention orders, restrictions and quarantine."

Alar Pharmaceuticals aims to fast track the approval of ALA-1000 through the 505(b)(2) regulatory pathway by consulting with the US FDA for the phase III pivotal study with partners.

About ALA-1000

ALA-1000 is designed as a subcutaneous injection to be administered once every three months, delivering Buprenorphine to treat opioid use disorder (OUD). The proposed buprenorphine systemic exposure resulting from the ALA-1000 injection remains effective over three months per administration and benefits patients by reducing the burden of daily administration, improving patient compliance, and diminishing the concerns of misuse, abuse and accidental pediatric exposure.

About Alar Pharmaceuticals

Established in 2016, Alar Pharmaceuticals Inc. (Alar), a new drug development company, focuses on developing long-acting release drug products for CNS disorders and chronic diseases, including opioid use disorder, chronic pain and major depressive disorder.