Benign Prostatic Hyperplasia (BPH)

LUTS/Retention

BACK

Watchful waiting

Medical management

Surgical approachesMinimal invasive TURPInvasive “open” procedures

Treatment options

“watchful waiting”

For mild symptoms. follow up 1 to 2 times yearly

Offer suggestions that help reduce symptoms

Avoid caffeine and alcohol Alteration of timing,volume of fluid intake

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Medical Managment2 major types:

Option 1: α 1 adrenergic blockers –“Relax” the smooth muscle of prostate and provide a larger urethral opening

Option 2: 5-α reductase inhibitors

“Shrink” the prostate glandOption

Growing Market Option

Combination of α 1 adrenergic blockers and 5-α reductase inhibitors– “Relax” and “Shrink” the prostate gland

Option 1 : Alpha (α) Blockers(relaxants)

• Prazosin, Terazosin, Tamsulosin• Relax the smooth muscle of the prostate, • Early- acting

Classifation of -Blockers• Nonselective– Phenoxybenzamine

• Short-acting selective a1-blocker– Prazosin, Alfuzosin

• Long-acting selective a1-blockers– Terazosin– Doxazosin

• Long-acting selective a1A-subtype– Tamsulosin– Alfuzosin-SR

Option 2: 5-α Reductase Inhibitors(shrinkers)(5ARI)

• Finasteride• Slow-acting• Taken orally as once daily for at least 6 months

Option 3: Combination – Separate or 2-in-1 Tablet

•“FinMax” (Finarid + Pimax)

•Duodart (Dutasteride + Tamsulosin)

•Tamplus (Finasteride + Tamsulosin)

“Combination therapy gives better outcome.”- Medical treatment of prostate symptoms study

Surgical Management:

“Gold Standard” of care for BPH

Uses an electrical “knife” to surgically cut and remove excess prostate tissue

Effective in relieving symptoms and restoring urine flow

TURP (transurethral resection of the prostate)

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Finasteride(FINARID)

5mg

FINASTERIDE

• is an antiandrogen which acts by inhibiting type II 5-alpha reductase, the enzyme that converts testosterone to dihydrotestosterone (DHT).

• It is used as a treatment in benign prostatic hyperplasia (BPH) in low doses, and prostate cancer in higher doses.

Benign Prostatic Hyperplasia (BPH)

Testosterone Dihydrotestosterone5-Alpha reductase Enzyme

Synthetic 4-azasteroid compound

Specific inhibitor of 5-alpha reductase

FINARID (Finasteride)

Mechanism of Action (“SHRINKS” the PROSTATE)

Testosterone Dihydrotestosterone

Synthetic 4-azasteroid compound

Specific inhibitor of 5-alpha reductase

FINARID (Finasteride)

Dosage and Administration

• Orally 5mg daily with or without food• Evaluate effect after 6-12 months• No dosage adjustment required in renal impairment

or otherwise• Not indicated in women and children• Box of 30’s = Box of 2 blister packs of 15 tabs per

blister pack

Attention Statement of Finarid

DETAILING FLAP (inner)

DETAILING FLAP

COMPETITORS

BRAND NAME GENERIC PACKING PRICE PER BOX PRICE PER TAB COMPANY1 AVODART Dutasteride 500mcg box of 30's 1,346.40Php 44.88Php GSK

2 PRONAX Finasteride 5mg box of 70'sIntas (Singapore Genebio)

3 PROSCAR Finasteride 5mg box of 30's 2,202.10Php 73.40Php MSD

4 PROSTAB Finasteride 5mg box of 30'sUnicure (Singapore Genebio)

5 PROSTANUS Finasteride 5mg box of 10's Sandoz6 PROSTERIDE Finasteride 5mg box of 30's Yoo Young

PIMAX (TAMSULOSIN 400 MCG)Tamsulosin

Clinical dataLegal status Prescription Only

Routes oral

Pharmacokinetic data

Bioavailability 100% (oral)Metabolism hepatic

Half-life 9–13 hoursExcretion 76% renal

Peak Plasma Concentration 6 hours (modified release)

How Tamsulosin Works• Smooth muscle tone is mediated by the sympathetic nervous stimulation

of α1 adrenoreceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck.

• Blocking these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and reduction in symptoms in BPH.

• Tamsulosin is a selective α1 receptor antagonist (blocking agent) that has preferential selectivity for the α1A receptor in the prostate versus the α1B

receptor in the blood vessels.

• Approximately 75% of the alpha1 receptors in the prostate are of the alpha1A subtype

Mechanism of Action

• TAMSULOSIN

“RELAXES”

the PROSTATE by blocking α1A receptors in the prostate.

Peripheral zone

Transition zone

Urethra

INDICATION

• Tamsulosin is primarily used for benign prostatic hyperplasia,

• But is sometimes used for the passage of kidney stones by the same mechanism of smooth muscle relaxation via alpha antagonism.(“off-label” indication)

Attention Statement of Pimax

Pimax Detailing Flap (inner)

Pimax Detailing Flap (outer)

Efficacy of Tamsulosin

• Tamsulosin has been reported to significantly improve BPH symptom scores and quality-of-life measures – after 1 week – and peak urinary flow within 4 to 8 hours of

administration.

DOSAGE and ADMINISTRATION

• Orally 200mcg or 400mcg or 1 tablet to be taken 30 minutes after the same meal each day

• Or as prescribed by the physician

Drug Combinations for the Treatment of Benign Prostatic Hyperplasia (BPH)

Alpha-Blocker and 5α-reductase InhibitorsSound drug combinations:

1. Alpha-blocker, PIMAX, for rapid symptom improvement and

2. 5α-reductase inhibitor, FINARID, for long-term shrinkage of the prostate.

The efficiency of the combination was demonstrated in randomized trials.

In the further course of the treatment, the alpha-blocker could often be discontinued after 3–5 months

COMPETITION

BRAND NAME GENERIC PACKING PRICE PER BOX PRICE PER TAB COMPANYDoxazosin Mesylate 4mg Tab box of 30's 2,079.00Php 69.30Php PFIZERDoxazosin Mesylate 8mg Tab box of 30's 2,504.69Php 83.49Php

3 CONMY Terazosin HCL 2mg box of 100's 4,450.00Php 44.50Php New Smart Formulae4 HARNAL D Tamsulosin HCL 200mcg box of 28's 2,155.28Php 76.97Php Astellas5 HARNAL OCAS Tamsulosin HCL 400mcg box of 30's 2,640.00Php 88.00Php Astellas

Terazosin HCL 1mg box of 100's 6,437.86Php 64.38Php AbbottTerazosin HCL 2mg box of 100's 8,785.57Php 87.86Php AbbottTerazosin HCL 5mg box of 48's 7,368.75Php 153.52Php Abbott

7 HYZIN Terazosin HCL 2mg box of 100's Hawon8 LOTENCIN Terazosin HCL 2mg box of 100's Genace Pharma9 PROFUZOSIN Alfuzosin HCL 10mg box of 30's Sandoz10 PROZELAX Tamsulosin HCL 200mcg box of 28's 1,434.19Php 51.22Php Biomedis11 SULOPROS Tamsulosin HCL 400mcg box of 14's and 28's12 TAMSOLIN Tamsulosin HCL 400mcg box of 10's Getz Pharma13 XATRAL OD Alfuzosin HCL 10mg box of 30's 2,379.43Php 79.31Php Sanofi-Aventis

1 ALFADIL XL

6 HYTRIN

DEALING WITH COMPETITION

• PRICE• AVAILABILITY• COVERAGE• RAPPORT/RELATIONSHIP• MONTHLY DRE ACTIVITIES• Other Productive Activities