BRAND INTRODUCTION

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 BRAND INTRODUCTION

SCIRICA
Pregabalin

75 MG Cap
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 THERAPEUTIC CLASS

SCIRICA
PREGABALIN

ANTIEPILEPTICS
ANTICONVULSANT
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 NERVOUS SYSTEM
MASTER SYSTEM OF THE BODY

BRAIN IS THE CONTROLLING CENTER

 CLASSIFICATION OF NERVOUS SYSTEM

ANATOMICAL FUNCTIONAL

CENTRAL NERVOUS SYSTEM MOTOR

SENSORY
BRAIN TRANSMIT IMPULSES FROM
TRANSMIT IMPULSES TO
SPINAL CORD CNS
CNS

PERIPHERAL NERVOUS SYSTEM

CRANIAL NERVES
SPINAL NERVES AUTONOMIC N.S SOMATIC N S
CENTRAL NERVOUS SYSTEM

Brain
Integrating or interceptive
component of the CNS

Spinal Cord
Thoroughfare for most
incoming & outgoing signals.
 PERIPHERAL NERVOUS
SYSTEM
Comprises of all nerve fibers lying outside the brain
& spinal cord

Role is to send stimuli to the CNS & carry the

responses back to the tissues
AUTONOMIC NERVOUS SYSTEM

Controls unconscious activities such as heart beat,

respiration, digestion & endocrine secretions of
hormones
SOMATIC NERVOUS SYSTEM

The sole function of the somatic nervous

system is to control skeletal muscle activity.
TRANSMISSION OF IMPULSE
NEURON
Basic structural unit of the nervous system
capable of integrating and transmitting
information in the form of electrical and
chemical energy
 NEURONS
(functional classification)
Motor neurons
• carry impulses from CNS to effectors

Sensory neurons
• carry impulses from sensory cells to CNS

Interneurons
• link the sensory and motor neurons with CNS
Neuron and impulse
transmission
 NEUROTRANSMITERS
In the chemical synapses, two cells communicate by a chemical agent
called a neurotransmitter, which is released by the pre-synaptic
neuron.
CENTRAL NEUROTRANSMITTER
Acetylcholine
Norepinephrine
Serotonin
Dopamine
Gamma amino butyric acid (GABA)

PERIPHERAL NEUROTRANSMITTER
Acetylcholine
Norepinephrine
 Neurotransmitters
NEUROTRANSMITTERS are the brain chemicals that
communicate information throughout our brain and body. .
There are two kinds of neurotransmitters
– INHIBITORY and EXCITATORY.
Excitatory neurotransmitters they are what stimulate the brain
and nervous system.
Inhibitory neurotransmitters Those that calm the brain and
help create balance are called inhibitory.
Balance mood and are easily depleted when the excitatory
neurotransmitters are overactive.
 Neurotransmitters
Inhibitory Neurotransmitters
SEROTONIN .
GABA is an inhibitory neurotransmitter when an excitatory
neurotransmitter is firing too often in the brain GABA will be sent out to
attempt to balance this stimulating over-firing.
DOPAMINE is a special neurotransmitter because it is considered to be
both excitatory and inhibitory.
Excitatory Neurotransmitters
DOPAMINE
NOREPINEPHRINE .
EPINEPHRINE
 Pregabalin
Pregabalin is a synthetic molecule and a structural
derivative of the inhibitory neurotransmitter γ-
aminobutyric acid.
γ-aminobutyric acid has analgesic, anticonvulsant,
anxiolytic, and sleep-modulating activities.
Pregabalin binds potently to the α2-δ subunit of calcium
channels, resulting in a reduction in the release of several
neurotransmitters, including glutamate, noradrenaline,
serotonin, dopamine, and substance P.
Normal process of
impulse transmission
1.Calcium ions enters into presynaptic
neurons through voltage gated
calcium channels.

2.These voltage dependent calcium

channels are present in areas of
nervous system dense in synaptic
connections.

3.These channels allow the selective

permeability of calcium ions across
presynaptic plasma membranes in
response to a presynaptic action
potential.
Normal process of
impulse transmission
4. Calcium activates the synaptic vesicles in
which neurotransmitters are stored. It
results in release of excitatory or
inhibitory neurotransmitters.

5. The released neurotransmitters cross the

cleft, binding to receptor molecules on
the next cell (Postsynaptic neuron),
prompting transmission of the message
along that cell's membrane.

6. In normal conditions, these

neurotransmitters are destroyed by
specific enzymes in the synaptic cleft,
diffuse out of the cleft, or are
reabsorbed by the cell.
Neuropathic pain
 IASP Definition of Pain

“Pain is an unpleasant sensory

and emotional experience
associated with actual or potential tissue damage or
described in
terms of such damage.”
WHAT IS
NEUROPATHY??
NEURO…
Derive from Neuron (Basic structural and functional unit of CNS)

PATHY…
Damage / Dysfunction / Disease

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 Diabetic Neuropathy can be defined as:

“The presence of symptoms and/or signs of peripheral nerve

dysfunction in people with diabetes after other causes have
been excluded”
 Features of Diabetic Neuropathy

Common complication affecting up to 50% patients with DM

Diagnosed in the presence of 2 abnormal symptoms or signs

Frequently asymptomatic & mostly untreatable

Requires careful examination/assessment to detect (NDS, NSS)

Affects quality of life (pain, depression)

Patients with DN are 15 times more likely to have LL amputation

Foot problems are the commonest reason for in-patient admission

Death most frequently due to cardiovascular disease

 What causes Diabetic Neuropathies?

Metabolic factors - such as high blood glucose, long

duration of diabetes, abnormal blood fat levels, and possibly
low levels of insulin

Neurovascular factors, leading to damage to the blood

vessels that carry oxygen and nutrients to nerves

Autoimmune factors that cause inflammation in nerves

Mechanical injury to nerves

Lifestyle factors, such as smoking or alcohol use

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 TYPES OF NEUROPATHY

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 Types of Neuropathy
• Peripheral neuropathy: Peripheral neuropathy is when the
nerve problem affects the nerves outside of the brain and spinal cord.
Accordingly, peripheral neuropathy is neuropathy that affects the
nerves of the extremities- the toes, feet, legs, fingers, hands, and
arms.
• Proximal neuropathy has been used to refer to nerve damage
that specifically causes pain in the thighs, hips, or buttocks.
• Cranial neuropathy: Cranial neuropathy occurs when any of the
twelve cranial nerves (nerves that exit from the brain directly) are
damaged.
• Autonomic neuropathy: Autonomic neuropathy is damage to
the nerves of the involuntary nervous system
• Focal neuropathy: Focal neuropathy is neuropathy that is
restricted to one nerve or group of nerves, or one area of the body.
 Neuropathy Causes
Nerve damage may be caused by a number of different
diseases, injuries, infections, and even vitamin deficiency
states.
• Diabetes:
• Vitamin deficiencies:
• Autoimmune neuropathy:
• Infection:
• Toxins and poisons can damage nerves.
• Drugs or medication:
• Trauma/Injury:
• Tumors:
• Idiopathic:
 TREATMENT OPTIONS

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 SCIRICA INDICATIONS
 Neuropathic Pain
Associated With
Diabetic Peripheral
Neuropathy

 Fibromyalgia

 Post herpetic
Neuralgia

 Chronic Low back Pain

 MOA OF SCIRICA

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 Neuropathic pain has a
complex pathophysiology
Hyper-excited neurone
◦ Hyper-excited neurone
pre-synaptic α2-
sub-unit releases excessive
Ca2+ excitatory
channe
l neurotransmitters
• Over-excitability at a
neurotransmitters
neuronal level plays an
post-synaptic
important role
in neuropathic pain1

1. Woolf CJ and Mannion RJ. Lancet 1999; 353: 1959–1964.

 Pregabalin modulates
hyper-excited neurones

Pregabalin
Modulation of hyper-excited neurone
by pregabalin*

• Pregabalin binds to the α2-

sub-unit of voltage-gated calcium
channels on pre-synaptic nerve
terminals, modulating calcium
influx into the cell1,2
• Affinity for the receptor six
times that of Gabapentin.

1. Fink K et al. Neuropharmacol 2002; 42: 229–236. 2. Field MJ et al. Poster presented at the International
Congress of NeuPSIG, 2004. 3. Gajaraj N Anesth Analg 2007;105:1805–15
 How does Pregabalin work???

Pregabalin binds with high affinity to the

alpha2-delta site ( voltage-gated calcium
channels) in Neurons

Reduces the calcium-dependent release

of several neurotransmitters (Glutamate ,
Substance P)

Increases neuronal GABA levels

Reduces neuropathic pain & also exerts

anticonvulsive and anxiolytic effects
According to NICE Guidelines-
Recommends Pregabalin for central and peripheral Neuropathic pain

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Approved Pregabalin in Central Neuropathic
pain associated with spinal cord injury.

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Recommends Pregabalin as the only drug
to earn a strong evidence level-A Rating.

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Recommends Pregabalin as
first line treatment for
neuropathies.

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 Product Profile-Pharmacokinetics
Pharmacokinetic Property Pregabalin

Absorption – Time to Cmax (h) 1.5

Bioavailability 90%

Effect of food on absorption ↓ rate

Protein Binding None

Metabolism Negligible

Elimination Renal

Half-life (h) 6.3

Dose-Concentration Relationship Proportional

 Fibromyalgia
•Fibromyalgia is a chronic condition characterized
by widespread pain in muscles, ligaments and
tendons, as well as fatigue and multiple tender
points, places on the body where slight pressure
causes pain.
•Fibromyalgia to be a disease of the central
nervous system.
 Diagnosis of
Fibromyalgia
The American College of Rheumatology (ACR) has
established general classification guidelines for
fibromyalgia to help in the assessment and study of
the condition.
• Diagnosis of fibromyalgia requires widespread aching pain of at least three
months duration
• Pain on minimum of eleven locations on the body that are abnormally
tender under relatively mild, firm pressure.
• Treatment of fibromyalgia includes both self care and medication to
minimize symptoms.
 Dosage and
Administration
Fibromyalgia

75 mg twice daily initially, increased to 150

mg twice daily within 1 wk based on efficacy
and tolerability. Patients not experiencing
sufficient benefit may further increase the
dosage to 225 mg twice daily (max, 450
mg/day).
Pregabaline Vs
Gabapentine

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 Features & Benefits
Features Benefits

SCIRICA binds with high affinity with Alpha-2

Relieves Patient from Neuropathic pain
Delta Receptor site

SCIRICA does not augment GABA (Gama

Relieves pain and improves sleep in patients
Amino Butyric acid) response in Neurons

Elimination half life of Pregabalin is 6 hours Less chances of withdrawal side effects in
which is less than Benzodiazepines patients of Neuropathies