Your Space - Health and Fitness

If you wake up with bruises all over your body from your sleeping partner using you as a punching bag during the night due to your incessant snoring, it might

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

be time to consider surgery to correct this problem. If you have tried behavioral techniques and conservative therapies such as CPAP for eliminating snoring an

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

everything has failed, see your doctor for advice on surgery options. Your insurance company may consider this an elective or cosmetic surgery. Surgery is a l

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ast resort and should only be used in the severest of cases or where serious health risks are involved, such as with sleep apnea. Surgery for snoring may be pe

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

formed as an outpatient procedure. In the surgical procedures described below, you can get an idea of the options your ontolaryngologist (an ear, nose and thro

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

t doctor) may recommend.

Somnoplasty: also referred to as Radio Frequency Tissue Ablation (RFTA) A minimally invasive procedure performed under local anesthes

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

ia that uses radiofrequency energy in the form of a needle electrode that discharges energy to reduce the soft tissue in the upper airway. After the procedure,

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

the body reabsorbs the tissue. This procedure often requires more than one application.

Uyulopalatopharyngoplasty (UPPP): also can be performed as laser assis

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ed uvuloplasty (LAUP). This procedure can be performed on people with mild apnea. LAUP and UPPP removes the soft tissue in the back of the throat and palate, w

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

idening the airway at the opening of the throat. UPPP corrects excess uvula tissue, enlarged tonsils or adenoids and excess tissue in the larynx. This is an in

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

atient procedure performed under general anesthesia and recovery time can be up to three weeks. Difficulty swallowing during recovery will be a result of this

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

rocedure. It is effective to decrease snoring and it cures 46-73% of all cases. With LAUP, the procedure involves using a laser to shorten the soft palate and

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

cutting away of the uvula. The two to five outpatient sessions required and administered four to six weeks apart, each session lasting 30 minutes. LAUP is not

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ecommended for apnea patients or light snorers but can be used for loud, disruptive snorers.

Mandibular maxillar advancement surgery: This invasive procedure

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

s recommended for patients with craniofacial abnormalities and reserved for people suffering from severe sleep apnea. The surgery corrects the anatomy of the t

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

hroat or face that is causing the apnea.

Nasal surgery: A procedure for patients with a deviated septum or other obstructions in the nose that are causing the

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

blockage of the airway.

Genio-Glossus Advancement (GGA): the genioglossus is the major tongue muscle that retracts, advances and depresses the tongue. This pr

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

cedure opens the upper breathing passage through operating on the tongue. Used for treatment of obstructive sleep apnea (OSA), it suspends the tongue to keep i

.

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

t from falling into the back of the throat during sleep. A tiny screw is inserted into the lower jawbone and prevents this from occurring. This procedure is us

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ally reversible. Additionally, tongue reduction surgery can be performed to minimize the size of the base of tongue, opening the airway and eliminating snoring

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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