#United States #Boulder #Alzheimer's Treatment #Mandara Biopharma #Dronabinol

Mandara Biopharma Moves Forward with Dronabinol for Alzheimer’s Agitation

Mandara Biopharma Inc., a U.S.-based biopharmaceutical company that is privately owned, has recently made significant progress in its quest to develop innovative therapies aimed at treating disorders of the central nervous system (CNS). The company announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) as it seeks to initiate clinical development for its dronabinol oral solution formulation. This particular formulation targets one of the most daunting challenges faced by Alzheimer's disease patients: agitation.

Agitation is not merely a distressing symptom for those dealing with Alzheimer’s; it also places an enormous strain on caregivers, healthcare providers, and long-term care facilities. According to research, this behavior manifests prominently in individuals suffering from Alzheimer’s, with around 60% of individuals battling mild cognitive impairment and an alarming 76% of dementia patients exhibiting agitation. These distressing episodes not only affect the quality of life for patients but also lead to increased operational costs, hefty workloads for staff, and a diminished standard of care, accounting for up to 6.1% of all institutional care costs associated with Alzheimer's, highlighting its economic and emotional toll.

David Hurley, the CEO of Mandara Biopharma, commented on the significance of this IND filing, expressing that it represents a crucial milestone for the company. "Filing this IND is an important milestone for Mandara as we advance a potential new therapeutic option for one of the most difficult aspects of caring for patients with Alzheimer's disease," Hurley stated. The aim is clear: if successful, this new treatment could become the first FDA-approved synthetic tetrahydrocannabinol (THC) prescription therapy specifically indicated for managing agitation tied to Alzheimer's disease.

The dronabinol oral solution formulation is being developed under an agreement with Benuvia Operations, LLC, a recognized global Contract Development and Manufacturing Organization (CDMO) based in the United States. Benuvia will assist Mandara by supplying and manufacturing the form of dronabinol necessary for clinical trials and potentially future commercial distribution. Terry Novak, CEO of Benuvia, emphasized the depth of expertise that his company brings to the table, particularly in the realm of developing and manufacturing regulated products within current good manufacturing practices (cGMP). He underscored the commitment to support Mandara’s clinical development program and looks forward to continuing this important partnership as they advance through the clinical phases.

The vision behind Mandara's therapy does not solely focus on providing a pharmaceutical solution—it aims at enhancing the overall experience of caregivers and patients alike. Alleviating agitation could substantially improve care quality and outcome measures for Alzheimer's patients, whose families often find the long-term care system overwhelming. With meticulous studies underway, the eventual goal is to provide an FDA-approved treatment that could deliver a meaningful impact in clinical settings.

Mandara Biopharma's innovative approach does not stop with Alzheimer’s agitation. The company envisions a broader pipeline of novel therapies targeting various CNS-related challenges. They expect to launch further developments in treating conditions such as traumatic brain injury by 2029 and post-traumatic stress disorder (PTSD) by 2030.

As Mandara Biopharma prepares to embark on the next steps of clinical development for its dronabinol formulation, the pharmaceutical and healthcare communities are watching closely. The potential to improve the lives of patients and alleviate the burdens placed upon caregivers could very well make Mandara’s efforts a pivotal turning point in the treatment of agitation associated with Alzheimer’s disease. In an age where mental health and cognitive disorders are only becoming more prevalent, this innovative clinical development represents hope—a beacon of possibility for those impacted by such debilitating conditions.

For more information about Mandara Biopharma and their initiatives, individuals can visit mandarabiopharma.com.

Conclusion

The filing of the IND for dronabinol marks a significant stride in addressing the pressing issue of agitation in Alzheimer's patients. As research and development continue, the hope is that such initiatives will culminate in enhanced therapeutic options that can change the landscape of Alzheimer's care.