Zolmitriptan

A N TI-MIGRAINE AGE NTS - 5-HT1 AGONISTS

Targeted Delivery

Capture the Market with Improved Patient Outcomes

 Zolmitriptan
Improved Patient compliance
Fast Growing in Blood Detection Time
Market Tablet Nasal Spray

15 Min 5 Min

Capture the Market with Improved Patient Outcomes

Market Analysis

Anti-Migraine Market Overview

12 11.1
11.1
▪ 12 % of US
Population suffers 10
from Migraine 8.3
8.3
8
▪ Migraine patients in
India >> US
6

▪ TRIPTANS ARE MOST 4.4

PRESCRIBED CLASS 4

▪ Triggers 2 11
Lifestyle/Food habits
Work-life balance 0
Environment Change Global Asia Pacific
Disease and Medicine US $ Billion CAGR

**Industry arc market research

Market Analysis – Zolmitriptan

Region MAT value (Million US $) CAGR Global Players

2021 ➢ Eli Lilly
➢ GlaxoSmithKline Plc
➢ AbbVie Pharmaceuticals
Global* 1036
➢ Astrazeneca
6%
➢ Impax Laboratories Inc.
United states** 446.7
➢ Amgen
➢ Lundbeck
*Data-intelo report ➢ Bristol-Myers Squibb Company
**IMS & Aurobindo
Market Analysis - India

Class MAT value 2021 CAGR %

(INR Crore)
Triptans 45.5 9
Zolmitriptan 2.6 1.7
Zolmitriptan Nasal spray 2.0 1.8

** AWACS SKU MAT

Top Zolmitriptan Brands/Companies
S.NO. Brand Formulation Company API Strength Price/M
RP
1. Zolmist Nasal Spray Cipla Zolmitriptan 5 mg X 7 650
2. Zolpax Nasal Spray Alteus Biogenics Zolmitriptan 5 mg X 7 537.24
3. Zomig Nasal Spray Global brand Zolmitriptan 5 mg US $
(Astrazeneaca – Innovator 621.88
not marketer)

4. Zolitas ODS Oral Intas Zolmitriptan 5 mg X 10 75

Disintegrating
Strip
5. Suminat Tablet Sun Pharm Sumatriptan 50 mg X 2 57.84

6. Headset Tablet Lupin Sumatriptan + 85mg + 500 mg 115.35

Naproxen X2
7. Snapit Tablet Abbott Sumatriptan + 85mg + 500 mg 115.55
Naproxen X2
Brands - Zolmitriptan Nasal Spray

GLOBAL
Manufacturer AstraZeneca (Innovator)
*Not marketer
Strength 5 mg / 2.5 mg
Formulation Single used
Pre-filled Spray device
Packaging 1 /2/6 Devices

Dose Quantity Per unit Price

US Price
2.5 mg 6 $103.65 $621.88
5 mg 6 $103.65 $621.88
Brands - Zolmitriptan Nasal Spray

INDIA
Manufacturer Cipla Ltd.
Strength 5 mg mg
Formulation Nasal spray
Packaging 7 metered doses spray device
MRP (INR) 650

MAT MAT Market share Market share

Value 20 Value 21 Zolmitriptan Class Zolmitriptan Nasal spray

1.5 2.0 Approx. 95% 100%

Zolmitriptan Nasal Spray
Formulation Metered Dose Intranasal Spray
Dose 2.5 mg/ 5 mg
Function Anti Migraine
Class Serotonin Analog
Route of Administration Intranasal
Delivery 15 Metered Nasal Spray
1 Spray eq 5mg Zolmitriptan USP
Pharmacokinetics Bioequivalent to Existing
formulations
Absorption and Onset 2-5 Minutes
 Zolmitriptan Nasal V/S Oral
Zolmitriptan Nasal Zolmitriptan Oral
Plasma Detection time 2-5 15 Minutes after Oral
Minutes after Nasal Administration
Administration
Migraine Relief Faster Slower than Nasal
Absorption and Distribution Targeted Absorption Non-targeted absorption
Bioavailability > Oral dose < Nasal dose
Patient compliance Better than Oral < than Nasal
(*can be given to sub-conscious
patients)
Safety and Efficacy Bioequivalent Bioequivalent
Patient compliance Better than oral Less than Nasal

•PMID: 17523769
• DOI: 10.2165/00044011-200525030-00006
Bioequivalence Studies
Stability Studies
Regulatory Documents
Dossier and Common Technical
Documents
**Available
 Plant Accreditations

❑ WHO – GMP
❑ ISO 9001:2015 ACCREDITATION
❑ HACCP
❑ FSSAI
❑ GLP
❑ NCB
❑ NCC
❑ SRILANKA – MOH
❑ GEORGIA-MOH
Migraine

➢A headache of varying intensity, often accompanied

by nausea and sensitivity to light and sound.

➢Migraine headaches are sometimes preceded by

warning symptoms. Triggers include hormonal
changes, certain food and drink, stress and exercise.

➢Migraine headaches can cause throbbing in one

particular area that can vary in intensity. Nausea and
sensitivity to light and sound are also common
symptoms.
Migraine – Pathophysiology
 Migraine – Pathophysiology
CGRP stands - Calcitonin gene-related peptide, and it is a protein that is released around the brain.
CGRP release, causes intense inflammation in the coverings of the brain (the meninges), and for most migraine
patients, causes the pain of a migraine attack.

- The trigeminal nerve is the part of the nervous system

responsible for sending pain, touch and temperature
sensations from your face to your brain.

At the start of a migraine attack, the trigeminal nerve

releases CGRP. CGRP causes blood vessels in the head to
swell.
It contributes to some inflammation around the brain.
Trigeminal pain pathways are activated.
Therapeutic Treatment
Zolmitriptan
Drug Class Triptans
Mechanism Serotonin agonist (5-HT1B/1D)
Use Acute treatment of Migraine
Dose 2.5 mg to 5 mg
May increase dose to 5 mg; not to exceed 5 mg per
single dose; individual response varies
May repeat dose if migraine has not resolved after 2 hr;
not to exceed 10 mg/24 hr

Bioavailability (Oral) 40 % (75% Cmax – 1 hour)

Half life 3 hours

Metabolism By Liver
Nasal dosage modification Not Required
Zolmitriptan

SEROTONIN AGONIST
Receptor : 5-HT1B/1D agonist
➢Triptan drugs work like a
brain chemical called
serotonin.
➢Promotes vasoconstriction
➢Inhibits vasoactive peptide
release
➢Inhibits brainstem pain
pathways
 Zolmitriptan Vs. Other triptans
Parameter Zolmitriptan Other triptans
Headache Response Better than other triptans Less than zolmitriptan
Patient compliance Low dose of administration Dose size is bigger
Pain relief over 24 hours Significantly more Significantly less