Lipocine Inc. (NASDAQ:LPCN), a pharmaceutical company, reported today that it has achieved positive topline results from a pivotal pharmacokinetic (PK) study demonstrating bioequivalence of its oral drug LPCN 1154 to the intravenous (IV) brexanolone, currently used for treating postpartum depression (PPD (NASDAQ:PPD)).
The study, which is critical for the company's New Drug Application (NDA) for LPCN 1154, met the U.S. Food and Drug Administration's (FDA) bioequivalence standards. These standards require that the Geometric Mean Ratios (GMRs) for key drug exposure metrics—such as the area under the curve (AUC) and the maximum concentration (Cmax)—fall within the 80% to 125% range when comparing the test product to the reference product.
Lipocine's study involved an open-label, randomized, crossover design with 24 healthy postmenopausal women. It compared the pharmacokinetics of a multi-dose regimen of oral LPCN 1154 to the IV infusion brexanolone using the approved high dose regimen. The study's primary goal was to determine whether LPCN 1154, intended for oral administration, is equivalent to the IV form of brexanolone in terms of drug exposure.
The results indicated that LPCN 1154 met the bioequivalence criteria with GMRs and 90% confidence intervals for Cmax, AUC0-∞, and AUC0-t falling within the FDA's specified range. Additionally, the trough concentration (Ctrough) of LPCN 1154 was higher than that of IV brexanolone, which was an intended outcome of the oral formulation.
LPCN 1154 was well received by study participants, with no severe or serious adverse events reported. The treatment was well tolerated, and the adverse events that did occur—such as venipuncture site reaction, headache, and fatigue—were mild to moderate in nature.
With these positive results, Lipocine is targeting an NDA submission by the end of the fourth quarter of 2024. The successful completion of this study marks a significant milestone for the company as it moves closer to potentially offering a more convenient oral treatment option for women suffering from PPD.
In other recent news, Lipocine Inc. has announced significant developments in two separate clinical trials. The company reported positive results from a Phase 2 trial of its obesity treatment, LPCN 2401, showing an increase in lean mass and a reduction in fat mass among participants. The trial focused on obese men, and the treatment led to a 4.4% increase in lean mass and a 6.7% decrease in fat mass over 36 weeks. The company is planning to discuss further development of LPCN 2401 with the FDA.
In a separate development, Lipocine also announced promising results from its Phase 2 clinical trial for LPCN 1148, a treatment candidate for cirrhosis. The study met its primary and key secondary endpoints, showing sustained skeletal muscle index improvements and fewer overt hepatic encephalopathy events among participants. The trial evaluated the efficacy and safety of LPCN 1148 in sarcopenic male patients with cirrhosis on the liver transplant waitlist over a 52-week period.
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