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As Lipocine's LPCN-1021 nears its FDA PDUFA date for a deficiency or absence of endogenous testosterone ("hypogonadism") what is the drug's potential?Ticker(s): LPCN, ABBV, ENDP, LLY
Institution: Johns Hopkins University
- Professor of Medicine and Oncology, Director of the Clinical Research Network, and Vice Chair for Faculty Development in the Department of Medicine
- Co-chairs the International Registry for Hypogonadal Men and serves as an investigator on several NIH-funded studies evaluating the relationship of sex hormones and cardiovascular risk
- Has published extensively on topics that include hormonal and other changes with aging and skeletal muscle decline and other effects of chronic disease on the gonadal axis
Please describe your background treating Low-T, including number of patients you see monthly and preferred treatment options.
How has your prescribing of testosterone therapies changed since the FDA guidelines in March 2015 indicated treatment should not be given to men experiencing Low-T due to natural aging? Have they at all?
What patients would you look to prescribe LPCN-1021 to? What % of your current patients on therapy would this represent? Are there patients in your practice not receiving therapy that you would look to start on this treatment?
How flexible do you expect the FDA to be with regards to the targets for secondary endpoints? How concerned should we be about the fact, that LPCN-1021 led to Cmax levels >1500ng/dL in 17.2% of patients (vs. <15% target)? How concerned should we be about levels >2500ng/dL seen in 2% of the patients (vs. 0% target)?
What were the reasons for the high drop out rate in the pivotal LPCN-1021 trial? Do you expect that the data would still meet the FDA's primary efficacy endpoint under an ITT analysis (LOCF)?
Since the LPCN trial based dose titration on Cavg (multiple samples drawn over 24 hours), how do the results compare to Androgel where the titration was based on a single sample drawn at a single time point. How will you implement this titration scheme in your clinic?Added By: tmd1
How concerning are elevated DHT levels and an abnormal DHT/T ratio with regards to the safety profile of LPCN-1021?
The Clarus oral TU produced peaks and valleys such that
patients spent on average 51% of the day with T less than 300 ng/dL. Is this a
feature intrinsic to all oral testosterone preparations? How does it compare to other routes of administration (like nasal or buccal) and what is the clinical significance of this finding?
How much difference were the miss on secondary endpoints from Androgel ?Added By: paulsco14
Didnt androgel miss secondary endpoints ?Added By: paulsco14
or were they too high in some casesAdded By: paulsco14
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- PDUFA June 28 2016 of LPCN 1021 for men with low testosterone LPCN Occurred On: Jun 29, 2016