Tuesday 6/20/17- Liposcine (LPCN), $4.02.
Announced results from both the Dosing Validation (“DV”) and the Dosing
Flexibility (“DF”) studies evaluating efficacy and tolerability of LPCN
1021. LPCN 1021 is an oral testosterone product candidate for
testosterone replacement therapy (“TRT”) in adult males for conditions
associated with a deficiency of endogenous testosterone, also known as
hypogonadism. The results from these studies confirm the validity of a
fixed dose approach without the need for dose titration to orally
administering LPCN 1021.
1021 successfully met the FDA primary efficacy guidelines in the DV study
where 81% of the subjects achieved average testosterone levels (“Cavg”)
within the normal range with a lower bound confidence interval (“CI”) of
72%. The DF study restored 70% of the subjects’ average testosterone
levels within the normal range (Cavg) confirming that twice daily
(“BID”) dosing is the appropriate dosing regimen for LPCN 1021 and will be
the basis for resubmission.
What They Do:
Lipocine Inc. is a specialty pharmaceutical company developing innovative
pharmaceutical products for use in men's and women's health using its
proprietary drug delivery technologies.
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