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Expert Interview

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

Another 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, ABBV, ENDP, LLY, Clarus Therapeutics

Who's the expert?

Name: Dr Culley Carson - MD

Institution: UNC

Bio:

  • Rhodes Distinguished Professor in the UNC Department of Urology. 
  • Specializes in the area of Men's Health, including the treatment of Peyronie's Disease, Erectile Dysfunction. and penile prostheses. 
  • Has published more than two hundred peer review publications and edited several textbooks. Dr. Carson currently serves in a number of national and international professional capacities, including as President of the American Society for Men's Health and Congress President for the International Society of Men’s Health.

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.

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
Q7.

Do you believe the FDA has a "class" bias against TRT because of perceived overuse, that may heavily influence
their 1021 decision?

Added By: userfaa1ee0e
Q8.

Food effect: will the food effect influence your prescribing pattern? Your monitoring of the patient? Will it worry you that a change in diet may change T levels in your patient?

Added By: zoron
Q9.

no cardiac hepatic or drug related SAE  ;
if there are no SAE's is this not important and telling

Added By: userfaa1ee0e
Q10.

What % of patients using gels continue on therapy after 3, 6, 12 mos? What is the reason for discontinuance- lack of benefit or gel annoyance? Do these patients generally resume therapy in the future or is the stable script rate a constant 3 mos turnover of new patients?

Added By: userfaa1ee0e
Q11.

What is the major reason patients seek TRT? sexual function,  general low energy, depression- all of the above?

Added By: userfaa1ee0e
Q12.

What is the typical patient profile- age range, BMI, symptoms? How do they come to be seeing you?

Added By: userfaa1ee0e
Q13.

Are most patients covered by insurance or are they self pay? How are low T patients stratified economically?
Is low T principally a lower income malady?

Added By: userfaa1ee0e
Q14.

When is TRT prescribed vs Viagra for sexual function? Are they competing products?
(ED is a comorbidity in almost 50% of all cases)

Added By: userfaa1ee0e
Q15.

Is testicular atrophy a result of TRT and do you think this a major reason patients end-up discontinuing therapy?

Added By: userfaa1ee0e
Q16.

Are there any concerns about Drug Drug interaction for this product?

Added By: joe_mccann
Q17.

You know they had one hematocrit AE correct? Please ask the expert about it

Added By: hbk_hbk

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