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Your Space - Viagra Can Treat, Not Cause Priapism
A team of doctors in the Johns Hopkins University is making waves among the medical fraternity, after they have come out succe
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
ssfully from a research, which proves that a PDE5 inhibitor like Viagra can treat and prevent recurring priapism in men.
Pria
Pria
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
pism is a disturbing and discomforting disorder among men, as men suffer from fatal, recurring erections that can have a debil
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
itating effect on his normal erectile functions, during each spell of priapism. Generally, men go through two types of priapis
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
m – ischemic or non-ischemic. The first case of priapism occurs due to idiopathic reasons, or reasons related to drug use, whi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
le the non-ischemic priapism is usually caused by traumas and other psychological factors. Priapism can occur either as an iso
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
lated episode, or occur recurrently at frequent intervals, almost everyday.
Previous researches have aptly demonstrated and e
Previous researches have aptly demonstrated and e
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
stablished that a dysregulated phosphodiesterase-5 (PDE5) plays an important role in the pathogenesis of priapism, giving a cl
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ear indication that PDE5 may serve as a molecular target for the treatment or prevention of the disorder. Dr. Burnett and his
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
colleagues in Johns Hopkins University, Baltimore, USA focused on this hypothesis to carry out the path breaking research.
Th
Th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e research team administered a long term PDE5 inhibitor treatment to three men with priapism due to sickle cell disease and a
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
man with complaint of recurrent idiopathic priapism. They were given 25 to 30 mg oral dosage of Sildenafil (Viagra) in the mor
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ning three times a week, for a long period of time.
The patients were closely followed and examined for a period of three to
The patients were closely followed and examined for a period of three to
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
eleven months, and it was found that the rate of occurrence of priapism gradually came down to very rare or occasional. The re
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
search team said that the encouraging results prove the dysregulated PDE5 hypothesis. It shows that this treatment resets the
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
erectile regulatory function of PDE5 back to normal and protects the penis from episodes of priapism.
The revolutionary resea
The revolutionary resea
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
rch defies conventional wisdom and judgment that Viagra and its class of drugs are contraindicated in patients with priapism.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
It would indeed be tough for a layman to fathom the fact that an erection enhancing medication like Viagra is used in the prev
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ention of an uncontrollable and never waning erection. The highly complicated research based on cellular regulatory model may
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
baffle you, as it challenges your traditional logic, but never forget that every discovery has been received in the same light
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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