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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
- 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.
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)?
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?
Do you believe the FDA has a "class" bias against TRT because of perceived overuse, that may heavily influence
their 1021 decision?
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?
no cardiac hepatic or drug related SAE ;
if there are no SAE's is this not important and telling
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
What is the major reason patients seek TRT? sexual function, general low energy, depression- all of the above?Added By: userfaa1ee0e
What is the typical patient profile- age range, BMI, symptoms? How do they come to be seeing you?Added By: userfaa1ee0e
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?
When is TRT prescribed vs Viagra for sexual function? Are they competing products?
(ED is a comorbidity in almost 50% of all cases)
Is testicular atrophy a result of TRT and do you think this a major reason patients end-up discontinuing therapy?Added By: userfaa1ee0e
Are there any concerns about Drug Drug interaction for this product?
You know they had one hematocrit AE correct? Please ask the expert about itAdded By: hbk_hbk
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