Advice Pool - Health and Fitness

Maria has been increasingly depressed for the past few years. She has tried at least four newer antidepressants but so far, she doesn’t seem to respond. Unable to work, she’s no

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

w feeling helpless and hopeless. Likewise, her family is discouraged. Frustrated and baffled by Maria’s lack of progress, the family doctor refers her to a psychiatrist.

What c

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

Examples of combination products may in

n the psychiatrist do to help Maria?

The psychiatrist has several options in dealing with a treatment-resistant or refractory depression. First, Maria’s psychiatrist can optimi

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

e the dose of her antidepressant. Maria has been taking low doses of antidepressants. In spite of her lack of response, the medication dosage has not been increased. To obtain a

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

clinical response, her psychiatrist should increase the dose every two to three weeks. The antidepressant can be adjusted up to the maximum allowable dose if no or only partial

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

Combination pro

response is observed.

Second, her psychiatrist can choose to augment the effect of her antidepressant with another medication such as lithium, triiodothyronine (T3), or buspiro

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

e. Among augmenters, lithium and triiodothyronine have the best support from the literature. Despite lithium’s efficacy, some doctors avoid this drug because it requires regular

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

blood monitoring and has unfavorable side effect profile such as acne, tremors, and thyroid and renal dysfunction.

Recently, studies have shown atypical neuroleptics such as ol

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

nzapine and risperidone to be good augmenters. In my opinion, further studies are necessary to establish these two drugs as standard augmenter. Indeed, research studies and clin

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

ical experience have found augmentation strategy to be effective.

Third, combination strategy is worthwhile to try. Maria’s psychiatrist can add another antidepressant to boost

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

the effect of her current antidepressant. For instance, trazodone can be added to an SSRI (serotonin reuptake inhibitor e.g. citalopram). Literature suggests that combining two

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

Following aspects would a

rugs with different mechanisms of action and drugs that involve several brain chemicals has resulted in clinical improvement. In this scenario, one antidepressant plus another a

dd to the challenges in developing combination products:

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

tidepressant is equal to three, or four or even ten, not two.

Fourth, the psychiatrist can switch from one antidepressant to another. Previous studies have shown that when maki

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

ng a switch, a drug should be replaced by a drug from a different class e.g. from SSRI to SNRI (serotonin and norepinephrine reuptake inhibitor e.g. venlafaxine), or from TCA (t

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

icyclic agent e.g. nortriptyline) to SSRI. But recent studies show that switching drugs within the same class (e.g. SSRI to another SSRI) is just as effective.

Fifth, Maria’s p

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

ychiatrist can also treat other ongoing symptoms or drug-related problems that further complicate her depression. If she is anxious and agitated, then her psychiatrist should pr

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

Professional from academic institutions, pharmaceutical industries, health care indust

scribe antianxiety drug (e.g. lorazepam) or if Maria is psychotic then adding an antipsychotic drug should help. Moreover, medication side effects (such as insomnia, dryness of

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

mouth, constipation, etc.) that negatively affect Maria’s compliance to the drug should be addressed promptly.

Lastly, if despite above measures Maria doesn’t respond to antide

.

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

ressants, then electroconvulsive therapy should be entertained. Of course, this procedure should be done with her consent.

In summary, Maria’s psychiatrist can optimize the dos

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

Companies that provide selfless information through particip

, augment or combine treatment, switch the medication, treat side effects and ongoing symptoms, or use electroconvulsive therapy for treatment-resistant or refractory depression

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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Advice Pool - Depression Series (Part 2): My Antidepressant Doesn't Work - What Can My Psychiatrist Do?

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