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A SECOND OPINION: As Lipocine's LPCN-1021 nears its FDA PDUFA date for a deficiency or absence of endogenous testosterone ("hypogonadism") what will the agency say?Ticker(s): LPCN, LLY, Clarus Therapeutics, ENDP
Name: Dr Darius Paduch - MD/ PhD
Institution: Weill Cornell Medicine
- Associate Professor of Urology and Reproductive Medicine and Associate Research Director of the Fellowship Program in Male Infertility and Andrology
- Has made significant contributions to advance our understanding of neurobiology of ejaculatory and orgasmic dysfunction in men and has developed new methods to measure arousal using ultrasonography: his research has led to the development of clinical trials to measure the effects of testosterone replacement on ejaculatory dysfunction
- Has published over 80 peer reviewed journal articles, 8 book chapters, and has given numerous invited lectures in the United States, Europe, and New Zealand.
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
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?
Clarus's had an advisory committee for REXTORO that ultimately resulted in an 18-3 vote to not recommend approval of the drug. LPCN did not have an advisory committee meeting called. What can we learn from the Clarus Ad-com as it relates to 1021?
Are high DHT levels of concern? Rextoro, another oral TU pill (albeit rejected by the FDA), had high DHT levels above normal range.
wouldnt they have had to report if the two patients that were high had adverse events? They reported no AE's ?Added By: paulsco14
The FDA advised that they do not need an Adcom for LPCN. Is this common practice and is it to be interpreted as positive or negative sign for approval?Added By: samskillz
Is the study size of about 300 participants low? Would this affect likelihood of approval?Added By: samskillz
There seems to be limited news or coverage of Lipocine. The company is fairly small with rare public announcements and follow on coverage by news outlets is light. What effect, if any, do these factors have on the FDA decision?Added By: samskillz
Does AbbVie's relationship with Lipocine have any impact on LPCN-1021 approval?Added By: samskillz
Does the fact that a pill does NOT have a black box warning re transference influence the advice you would give to patients?
patients drop off after 3 mo of therapyAdded By: userfaa1ee0e
trt causes infertlity, not for reproductive plans?Added By: userfaa1ee0e
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