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Expert Interview

Slingshot members are talking to an expert! The topic is:

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

Who's the expert?

Name: Dr Darius Paduch - MD/ PhD

Institution: Weill Cornell Medicine

Bio:

  • 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.

Interview Questions
Q1.

Please describe your background treating Low-T, including number of patients you see monthly and preferred treatment options.

Added By: joe_mccann
Q2.

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?

Added By: joe_mccann
Q3.

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?

Added By: joe_mccann
Q4.

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)?

Added By: joe_mccann
Q5.

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)?

Added By: joe_mccann
Q6.

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: joe_mccann
Q7.

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?

Added By: joe_mccann
Q8.

Are high DHT levels of concern? Rextoro, another oral TU pill (albeit rejected by the FDA), had high DHT levels above normal range.

Added By: zoron
Q9.

wouldnt they have had to report if the two patients that were high had adverse events?  They reported no AE's ?

Added By: paulsco14
Q10.

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
Q11.

Is the study size of about 300 participants low? Would this affect likelihood of approval?

Added By: samskillz
Q12.

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
Q13.

Does AbbVie's relationship with Lipocine have any impact on LPCN-1021 approval?

Added By: samskillz
Q14.

Does the fact that a pill does NOT have a black box warning re transference influence the advice you would give to patients?

Added By: zoron
Q15.

patients drop off after 3 mo of therapy

Added By: userfaa1ee0e
Q16.

trt causes infertlity, not for reproductive plans?

Added By: userfaa1ee0e

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