LPCN 2201 – Major Depressive Disorder

LPCN 2201 – Major Depressive Disorder

Oral Rapid Acting Anti-depressant (RAAD) 
Novel treatment paradigm
Meaningful improved tolerability

Product Candidate: LPCN 2201

Oral Rapid Acting Anti-depressant (RAAD) for Major Depressive Disorder (MDD) 

Product Attributes: 

LPCN 2201 with its novel MOA, superior benefit to risk profile, and potentially few label encumbrances than conventional antidepressant, is being advanced for MDD.
 
Oral Brexanolone is chemically identical to the endogenous human hormone allopregnanolone, a neuroactive steroid and positive allosteric modulator of y-aminobutyric acid (GABAA) receptor.
 
LPCN 2201 is being developed to provide a novel, rapid relief, oral treatment option for MDD, aiming to improve outcomes without the limitations of existing therapies. It has the potential to promote acute stabilization of symptoms with the freedom of “at home” dosing, while presenting no significant risk of adverse reactions from exposure to bioidentical brexanolone.
 
LPCN 2201 is targeted to be an appealing option for patients with MDD in whom rapid improvement is a priority.

About Indication:

Depression is one of the leading drivers of workplace productivity loss worldwide. 

Major depressive disorder (MDD), also known as clinical depression, affects approximately 21 million adults in the U.S., representing 8.4% of the population. 

Clinical depression symptoms may include depressed mood, loss of interest in daily activities, change in sleep, appetite or weight, fatigue, diminished concentration or slowed thoughts, feelings of worthlessness and/or suicidal ideation.

In 2018, the total annual burden of medication-treated MDD in the U.S. was $92.7 billion.

Patients often express concerns related to the inadequacy of available treatments, incomplete treatment response, and the side effect burden of available MDD treatments

Newer MDD rapid relief options come with significant cost burdens and face significant challenges, including black box warnings for sedation, dissociation, cognitive impairment, and increased blood pressure. Beyond safety, access remains a major hurdle for newer rapid relief options with in-clinic administration in a clinical setting being the norm for most RAADs approved or under development, which greatly limits convenience and scalability. 

Patients and providers urgently need a convenient, well-tolerated, at-home rapid relief option for MDD. Ideal solutions should offer ease of use without monitoring requirements, enabling treatment in outpatient or home settings. 

A preferred RAAD is expected to deliver effective antidepressant action with high and sustained remission rates, while maintaining a wide therapeutic index for safety and tolerability. Improved compliance, better management of comorbid conditions such as anxiety, and enhanced patient experience are critical to addressing the gaps left by current therapies. 

Oral Brexanolone for Major Depressive Disorder (MDD)

Innovating beyond
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