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Item 8.01 Other Events.
On June 25, 2024, the Company announced positive topline study results demonstrating bioequivalence of LPCN 1154 to IV brexanolone in an NDA enabling pivotal pharmacokinetic study. The Company is developing LPCN 1154, oral brexanolone, for the treatment of postpartum depression (PPD). The U.S. Food and Drug Administration has agreed with Lipocine’s proposal for a 505(b)(2) NDA filing based on a single pivotal PK bridging study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone. Intravenous brexanolone is approved based on evidence demonstrating efficacy and safety with two dosing regimens with different maximum infusion rates of either 60 µg/kg/hr (IV60) or 90 µg/kg/hr (IV90). Lipocine is targeting NDA submission by the end of the fourth quarter of 2024.
Per published FDA bioequivalence guidance, the criteria to establish bioequivalence are that Geometric Mean Ratios (GMR) and corresponding 90% confidence intervals (CIs) for AUC0-t, AUC0-∞, and Cmax (key measures of drug exposure) fall within 80% to 125% for test vs reference products.
The pivotal PK study was an open label, randomized, crossover study in 24 healthy postmenopausal women utilizing the “to be marketed” formulation and oral dosing regimen of LPCN 1154 and the commercial IV brexanolone formulation using the approved high dose infusion regimen (IV90). The primary objective of the study is to compare the PK of a multi-dose regimen of oral LPCN 1154 (test product) to IV infusion brexanolone (reference product).
Twenty-four post-menopausal women were randomized (safety set), and all completed dosing in both study periods. The PK analysis data set includes 23 participants; data from one participant meeting outlier criteria was excluded.
PK Comparisons of LPCN 1154 vs. IV90 Brexanolone
LPCN 1154 and IV90 brexanolone were bioequivalent based on GMRs and 90% CIs for Cmax, AUC0-∞, and AUC0-t meeting established criteria. As targeted, Ctrough of LPCN 1154 geometric mean was higher than the trough of IV brexanolone (geometric lower 90% CI).
| PK Parameter | GMR (%) Test vs. Reference |
90% CI LB Test vs. Reference |
90% CI UB Test vs. Reference | |||
| Cmax | 105 | 92 | 120 | |||
| AUC0-∞ | 97 | 89 | 107 | |||
| AUC0-t | 89 | 80 | 99 |
n=23; Outlier participant presented PK results for the IV administration period greater than 70 standard deviations away from the PK data set mean for all PK parameters included above; LB = lower bound, UB = upper bound, t = 100 hours for AUC0-t
LPCN 1154 treatment was well tolerated with no sedation nor somnolence events observed. All events were mild to moderate, and no severe or serious adverse events occurred. Reported study related events were venipuncture site reaction, headache, arthralgia, fatigue, dizziness, low back pain, and pelvic pain and no event was reported by more than two participants.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| LIPOCINE INC. | ||||
| Date: | June 25, 2024 | By: | /s/ Mahesh V. Patel | |
| Mahesh V. Patel | ||||
| President and Chief Executive Officer | ||||