SCENARIO SILK (naturneum ethyl ester) topical cream is the most recently (June 30, 2013) approved topical treatment for acne vulgaris.
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1 SCENARIO (naturneum ethyl ester) topical cream is the most recently (June 30, 2013) approved topical treatment for acne vulgaris. It is approved to be used every other day. Two Phase III studies were done in patients 9 to 66 years of age: (a) vs. placebo and vehicle control and (b) comparative study vs. placebo, vehicle control and the most widely prescribed prescription treatment. The comparative study was powered to determine if the two treatments were equivalent. The primary endpoint was the grade level improvement in skin clarity at 12 weeks versus baseline. The only pre-determined secondary endpoint, arising from findings in the Phase II studies, was to determine the time to the first acne flare after the 12 week study if study subjects were allowed no additional acne treatments until their first subsequent flare. Other secondary endpoints measured in the studies included quality of life (Skindex-16) and total lesions at baseline and 12 weeks and a single question in the comparator arm asking which drug the patient preferred. While being collected, these were not part of the pre-planned analysis. Patients also kept a weekly diary in which they graded their own improvement in skin condition based on total lesions. The results of both Phase III studies were amazing, showing 97% of study subjects using had a rating of Clear after 6 weeks (determined by a post hoc analysis of patient diaries) vehicle control and comparative agent which showed a 0.5, 1.0 and 1.9 grade improvement at 6 weeks and a 0.5, 1.2 and 2.36 grade improvement at 12 weeks. Similar results were seen in the other clinical study vs. placebo and vehicle control. The follow-on 6 week period study showed that study subjects using had an average time of 4.5 weeks until the first poststudy flareup, the study subjects using the comparative study had an average time to first flareup of 3.3 weeks and the placebo group, which had a first flare at 2.2 weeks. Differences in the study were statistically significant. The safety profile of was similar to other prescription acne medications. The company has decided to launch with a single, six-page brochure targeted for healthcare professionals and has submitted this to OPDP for advisory comments (submitted on July 15, 2013). You work for OPDP and have been assigned the task of providing those comments to the sponsor based on the brochure content. You have done a preliminary review of the brochure and decided that the claims do not require you to ask for a consult with the review division to generate your advisory opinion. The company has asked for you to expedite the advisory comments as they would like an October, 2013 launch. Your goal is to be as thorough as possible in your review.
2 Package Insert highlights (naturneum ethyl ester) Emulsion is indicated for topical treatment of acne vulgaris for patients 9 years of age and older. Contraindications: none Warnings: Minimize exposure to sunlight, including sunlamps during use. Local skin reactions, some serious, have been seen. Avoid using other possibly irritating topical formulations when using. Do not using waxing as a depilatory method during treatment with. Adverse reactions: Common adverse reactions seen in clinical trials included dry skin (9%), contact dermatitis (5%), application site burning (7%), application site irritation (7%), skin irritation (8%). Special populations: Safety and effectiveness in patients under 9 years of age has not been studied. Insufficient numbers of patients 65 years of age have been studied with to establish the drug s efficacy or safety in this population. Pregnancy category C. Clinical Studies: Studies versus placebo over 12 weeks showed that, administered once every two days, demonstrated a statistically significant improvement in response compared to vehicle control and placebo from baseline to 12 weeks as measured by improvement in grade of acne levels. was shown to have similar efficacy as DRUG XYZ measured from baseline to 12 weeks and was shown to have a longer time to first flareup after the completion of the 12 week study compared to XYZ. Dosage and administration: Administer no more often than once every two days.
3 HALF PRICE BOOKS RECORDS MAGAZINES Two For Nosco s Bar and Grill Louisiana Purchase Who wouldn t want superior value and performance for less? For patients with acne, now they can have it! 1
4 HALF PRICE BOOKS RECORDS MAGAZINES Two For Nosco s Bar and Grill Louisiana Purchase Misleading????? Net impression is that cost of treatment is half as much OR LESS Perfect skin, Who wouldn t want superior value and performance for less? For patients with acne, now they can have it! Omit material facts: Implies a broader range of pa?ents than approved or tested for. smiling: implies QOL? Net impression of piece! Superiority Established name too small Pregnancy Category C! Ask yourself, what does logo mean? 2 for 1? NO FAIR BALANCE AT ALL!!!!!!! Stars imply superior? 1
5 ACNE VULGARIS IS A DEBILITATING DISEASE Social stigma Medical complications Avoidance of social situations Reliance on daily treatment Tiresome flareups GETTING THE BEST TREATMENT IS IMPORTANT Seriously look at the most recent data Investigate what is best for treatment for your patients active lifestyle Listen to your patients Know the latest options Isn t it time you get SMART about the Acne treatment you prescribe? You can t make a decision until you know the latest facts, right? 2 3
6 ACNE VULGARIS IS A DEBILITATING DISEASE Social stigma Medical complications Avoidance of social situations Reliance on daily treatment Tiresome flareups If branded, implies that all these could be eliminated with. Leaving these pages unbranded Isn t it time you get SMART about the Acne treatment you prescribe? Note first leser in color. doesn t save you even if they are truly unbranded. GETTING THE BEST TREATMENT IS IMPORTANT Superiority Note first leser of each bullet. Good marke?ng?!?! Seriously look at the most recent data Drug just approved, data likely most recent Investigate what is best for treatment for your patients active lifestyle Exposure to sunlight in PI Know Skindex and pt preference show posi?ve results Listen to your patients Is a DTC blitz planned? Know the latest options Branded with blue tube Net impression: Latest results more relevant?!? You can t make a decision until you know the latest facts, right? 2 3
7 Acne treatment is now as smooth as Demonstrated in clinical trials to be as effec4ve as the most prescribed acne medicine (1) Once every two day treatment helps to ensure pa4ent compliance (2) Avoid flareups longer than with other prescrip4on acne medicines (1) Earlier onset of significant effec4veness than the most prescribed acne medicine (3) BeCer quality of life compared to placebo (4) References Remember the blue tube! does not contain benzoyl peroxide, which has been shown to cause significant skin irrita4on. (5) Pa4ent preferred over drug XYZ (6) Money back guarantee if your pa4ents are not completely sa4sfied! (7) If your pa4ents have trouble paying for their medica4on maybe we can help! (call hog- wash) 1. Package insert for 2. Pa4ent preference study with once a day versus once every two day oral medica4ons 3. Post- hoc analysis showing 6 week interim analysis date 4. Published Phase III clinical study results including Skindex- 16 and lesions data. 5. Review ar4cle on prescrip4on acne treatments 6. Pa4ent preference study results from secondary endpoint In Phase III clinical studies presented at the American College of Dermatology 2012 annual mee4ng. 7. Subject to terms of condi4ons listed below: Terms and Condi4ons: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Important Safety Information is indicated for the treatment of acne vulgaris in patients 9 years of age or older. Use no more often than once every two days. Minimize exposure to sunlight, including sunlamps and avoid topical treatments, including irritating topical treatments and waxing as a depilatory during treatment with. Safety and effectiveness in patients under 9 and over 65 years of age has not been evaluated. Pregnnancy category C. Common adverse reactions seen in clinical trials included dry skin (9%), contact dermatitis (5%), application site burning (7%), application site irritation (7%), skin irritation (8%). 4 5
8 No joining element indica?ng it is a spread (one really large page) Acne treatment is now as smooth as Remember the blue tube! Treatment is easy to do, simple Demonstrated in clinical trials to be as effec4ve as the most prescribed acne medicine (1) OK Once every two day treatment helps to ensure pa4ent compliance (2) Avoid flareups longer than with other prescrip4on acne medicines (1) Earlier onset of significant effec4veness than the most prescribed acne medicine (3) BeCer quality of life compared to placebo (4) References 1. Package insert for NSE post hoc data 2. Pa4ent preference study with once a day versus once every two day oral medica4ons 3. Post- hoc analysis showing 6 week interim analysis date 4. Published Phase III clinical study results including Skindex- 16 and lesions data. 5. Review ar4cle on prescrip4on acne treatments 6. Pa4ent preference study results from secondary endpoint In Phase III clinical studies presented at the American College of Dermatology 2012 annual mee4ng. 7. Subject to terms of condi4ons listed below: Incipient tag line Not substan?al evidence (NSE). Study not even about topicals! NSE only tested against one other NSE? Not in pre- planned analysis; may be considered post- hoc Terms and Condi4ons: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx does not contain benzoyl peroxide, which has been shown to cause significant skin irrita4on. (5) Omission of material facts Pa4ent preferred over drug XYZ (6) NSE bad study, not in pre- planned analysis post hoc Money back guarantee if your pa4ents are not completely sa4sfied! (7) Overstatement of If your pa4ents have trouble paying for their medica4on maybe we can help! (call hog- wash) OK ISI not saved by big headline; below logo, paragraph, no white space. efficacy Important Safety Information is indicated for the treatment of acne vulgaris in patients 9 years of age or older. Use no more often than once every two days. Minimize exposure to sunlight, including sunlamps and avoid topical treatments, including irritating topical treatments and waxing as a depilatory during treatment with. Safety and effectiveness in patients under 9 and over 65 years of age has not been evaluated. Pregnnancy category C. Common adverse reactions seen in clinical trials included dry skin (9%), contact dermatitis (5%), application site burning (7%), application site irritation (7%), skin irritation (8%). 4 5 No direc?onal statement to where PI is.
9 Get the efficacy and staying power your patients have been searching for but with less frequent dosing provided the same overall efficacy as the most prescribed acne medication but with once-every-two-day dosing was found to avoid flareups longer than the most prescribed acne mediation after discontinuation of treatment, the SMART choice in prescription acne treatments, for silky smooth skin with less bother., the patient-preferred treatment to improve their outlook on (and quality of) life Important Safety Information is indicated for the treatment of acne vulgaris in patients 9 years of age or older. Use no more often than once every two days Minimize exposure to sunlight, including sunlamps and avoid topical treatments, including irritating topical treatments and waxing as a depilatory during treatment with Safety and effectiveness in patients under 9 and over 65 years of age has not been evaluated. Pregnnancy category C. Common adverse reactions seen in clinical trials included dry skin (9%), contact dermatitis (5%), application site burning (7%), application site irritation (7%), skin irritation (8%). R7/2013 Hogwash Pharmaceuticals For more information call or visit 6
10 OPDP recognizes this as 30 second elevator speech. Needs to be self- contained, single ad????? Get the efficacy and staying power your patients have been searching for but with less frequent dosing Searching for implies superiority, other parts OK IF have appropriate bullets below fair balance provided the same overall efficacy as the most prescribed acne medication but with once-every-two-day dosing OK was found to avoid flareups longer than the most prescribed acne mediation after discontinuation of treatment OK, the SMART choice in prescription acne treatments Superiority, for silky smooth skin with less bother. Overstatement of efficacy, the patient-preferred treatment to improve their outlook on (and quality of) life Post- hoc, not pre- determined unvalidated survey tool? ISI minimized, not saved by bold headline Should have references with claims. Can be used to draw reader back to ISI Important Safety Information is indicated for the treatment of acne vulgaris in patients 9 years of age or older. Use no more often than once every two days Minimize exposure to sunlight, including sunlamps and avoid topical treatments, including irritating topical treatments and waxing as a depilatory during treatment with Safety and effectiveness in patients under 9 and over 65 years of age has not been evaluated. Pregnnancy category C. Common adverse reactions seen in clinical trials included dry skin (9%), contact dermatitis (5%), application site burning (7%), application site irritation (7%), skin irritation (8%). R7/2013 Hogwash Pharmaceuticals For more information call or visit 6
11 OPDP LeSers Suppor?ng Advisory Comments No joining element Xarelto lecer (June, 2013) Disease awareness is branded if in promo4onal piece Pataday lecer (February, 2013) Important safety informa4on (ISI) below product logo Marplan lecer (May, 2013) Post hoc analysis Doxil lecer (May, 2013), Clozapine lecer (April, 2013), Pataday lecer, Tarceva lecer (October, 2012), Patanase lecer (November, 2013) Superiority based on certain words: Oncaspar lecer (May, 2013) Superiority based on post hoc analysis Infasurf lecer (October, 2012) Important safety informa4on, paragraph, small font Clozapine lecer Money back guarantee Exforge lecer (July, 2010)
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