Tasimelteon, Sleep Disorder Drug, Shows Promising Result

Tasimelteon was able to pass the second trial which was late stage and the results were good. It is effective against a rare condition called NON-24: Non 24 hours sleep wake disorder.

NON -24 is a sleep cicadian rhythm disorder, the characteristics are like the person falls asleep and gets up hourly late, as the body clock cannot adjust properly to the cycle of dark and light. As a result people feel tired and exhausted during the day. The disorder is rare and can happen to 1 out of 2000 people; however it is common in people who are blind.  There is no approved treatment for it yet.

Vanda’s drug helps to regulate circadian rhythm and act as melatonin agonist. The master clock in hypothalamus is reset, that stabilizes cortisol and melatonin rhythms back to 24 hours cycle of night and day.
To check the safety and efficiency of the drug a study was conducted where people were treated.

Trial result were impressive
Tasimelteon was better as compared to Placebo, in the first late stage. 20mg of Tasimelteon was given to 20 patients for 2 months. The effectiveness of the drug was displayed in the first trial itself showing entertainment melatonin superiorly maintained in Tasimelteon patients.

The second trial had same results, where cortisol rhythm was maintained better in Tasimelteon as compared with Placebo patients. Hence they had normal and better sleep.

As said by Steven W. Lockley, Ph.D. from Division of Sleep Medicine in Brigham and Women's Hospital also he is Harvard Medical School teaching affiliate.

The result prove that Tasimelteon can entertain the circadian clock and to maintain the same the continue treatment is required. The entertainment should be also beneficial clinically and to treat NON-24 the master clock has to be entertainment needs to be maintained.

Vanda Pharmaceuticals Inc shares have gone up after this and they said that approval request will be send this midyear.

Mihael H. Polymeropoulos, CEO M.D and President, Vanda said that –

“We are happy with the result as this will help us to treat blind Non-24 patients. Also the result made a mark that for treating Non-24 chronic therapy is important. Once it is approved we are sure that Non-24 patient’s life will improve.”

Replacement For Viagra is Stendra, FDA Approves Stendra

FDA has approved new erectile dysfunction drug developed by Vivus. The drug has been named as Stendra.

With this development, Vivus has finally managed to get first approval for its product. The approval came in time when patent of Viagra is about to expire. Stendra is expected to be replacement for Viagra. The drug manufacturer is also hoping approval for its weight loss drug called Qnexa which is in reviewal process.

Stendra is brand name of Avanafil. Earlier we had reported development of Avanafil, and the drug has got approvalfrom FDA. Currently there are three FDA approved erectile dysfunction drug treatments namely, Viagra; Cialis; Levitra. Generic Viagra is most popular drug. Being top popular drug, pharmaceutical companies were competing to take place of Viagra when its patent expires.

What is Erectile Dysfunction?

Erectile Dysfunction is a disorder characterised as a man is unable to get erection or maintain erection or erection is not rigid enough for sexual intercourse. FDA estimates around 30 million suffering by erectile dysfunction caused by various reasons.

How Stendra Works?

Like other drugs, Stendra also works by increasing blood flow in penis which eventually results in erected penis.

How To Take Stendra for Best Effect?

Stendra is recommended to take half an hour before intercourse. Medical experts have seen Stendra producing effect within fifteen minutes. The time of action is maximum and can be less for other patients. Stendra is thus the fastest acting erectile dysfunction drug.

Stendra Side Effects

FDA has strictly advised patients not to take Stendra if patient is taking nitrate drug. Stendra is contraindicated to nitrate drugs and may lower blood pressure. Side effects reported by FDA are vision problem. Since Stendra is also PDE5 inhibitor drug it can cause vision loss in single or both eyes. Hearing problem is another side effect likely to develop in some patients.

Headache, nasal congstion, redness at several parts of body and back pain are common side effects observed by FDA review panel.

FDA has approved 1st biologic medication for children with ulcerative colitis (UC)

The U.S. Food and Drug Administration (FDA) has approved Remicade (infliximab) to moderately treat the vigorous ulcerative colitis (UC) in patients younger than six years, and have a insufficient reaction to the unconventional therapy.

There are around 1.4 millions of Americans adults and kids living with inflammatory bowel disease (IBD). Its is said that they are split between ulcerative colitis (UC) and Crohn’s disease. Predictably there are 150000 children below the age of 17 who are living with the symptoms of inflammatory bowel disease (IBD).

Ulcerative colitis (UC) is a kind of inflammatory bowel disease (IBD) that distress the inside layer of the large intestine (colon) and rectum and the cause of ulcerative colitis (UC) is still unidentified. Ulcerative colitis (UC) can affect people for all age group, even thought it is high to be affect at the age of 15-30.

Earlier there was no approved therapy for ulcerative colitis (UC) which is a distressing disease and had an insufficient respond to this conventional therapy. Due to this approval, Remicade (infliximab) represents an unconventional treatment in treating children suffering from inflammatory bowel disease (IBD).

Remicade (infliximab) permit is supported by the proof from a sufficient and well controlled study in young ones suffering from ulcerative colitis (UC). Treating ulcerative colitis (UC) with infliximab, strength 5 mg/kg has clinically responded to the patients in 8 weeks and established a safe profile, with a clinical examination carried out in adults as well.

In small kids all the vaccines should be up to date prior to initiating the medication with infliximab and should avoid receive vaccination while treating with infliximab. Few of the most frequent side effects of infliximab is worsening of ulcerative colitis (UC), respiratory infections, and headache.

Under Trial Chemotherapy Drug Gets Positive Response by FDA

For a targeted treatment, developed by Seattle Genetics is in trial and the company is seeking for approval with conditions. FDA has asked monitoring committee for more clinical trial data that would back the conditional approval.

FDA on Tuesday issued documents to be considered by advisory committee in the wake of company's conclusion inferred from clinical trials. No major-safety concerns were raised in documents.

The under-trial drug is brentiximab vodotin with given Adcentris as brand name. Brentiximab is indicated to treat lymphom, a type of cancer which has not responded other available treatments. The drug is believed to be effective for treatment of Hodgkin and anaplastic lymphoma by increasing effects minimizing side effects of chemotherapy. It is co-developed with japan's pharmaceutical company.

The proposed cancer treatment drug is being reviewed by cancer drugs panel of FDA. Panel also includes some non-FDA medical personnel. FDA has asked the panel to vote on whether it can approve the drug or not.

Final decision is likely to come out in August. FDA is free to take or not to take advice from the panel.

Effect of positive notion from FDA can directly be seen on stock value of the company. Shares of Seattle Genetics have risen sixty two percent in a year.

Market experts took the released documents positive as no major concerns were there which may prevent the approval. However, company woun't be able to cash in on its product if the drug is approved for Hodgkin lymphoma only.

Estimated annual sales for the drug could be between $450-$500 million.

Testosterone Gel by Teva Nears Approval

Bio-T-gel is the new gel that claims to treat Hypogonadism and is set on to pass the last stage of clinical trials for the approval of FDA (Food And Drug Administration).

This testosterone gel ash already passed the entire previous test and is supposed to clear the last stage which has to be done before November 2011. Manufactured by BioSante Pharmaceuticals and later passed to Teva pharmaceuticals, it is gearing up for further process. Testosterone is what makes men. It is what offers the men his masculine characteristics. The deepening of voice and the muscles that he flaunts is all because of testosterone. When testosterone is lower than 300 nanograms per deciliter of blood, it is considered to be a sign of low testosterone level in your body. With over 1.2 $ billion of market share in the testosterone industry, it has further scope to grow. Also with around 4-5 million men being affected by low testosterone levels, they surely need more of such treatment. Also Teva is completely confident and optimistic about their results. Stepehn Simes who is the CEO and President of this company has been excited and is working on the further steps. Low testosterone can further lead to other sexual problems like erectile dysfunction, depression, stress etc.

So a new gel in this field can only be considered to be a blessing.

For the first time FDA approves a drug for treating Melanoma

Till this date the pharmacy and medical science have failed in delivering a medication that could cure Melanoma. Whatever drug was presented to treat this disorder, it was seen that they were somewhere below the standards of FDA (Food And Drug Administration). Dr. Richard Pazdur who is the director of the Office of Oncology products for drug evaluation and research in the department of the FDA (Food And Drug Administration). On the other hand, Melanoma is posing an increasing threat. The latest statistics reveal that Melanoma is rising since 2010. Especially in U.S around 8300 men have died due to this disorder. This research was carried out by the National Cancer Institute. Melanoma is fatal and can the last stage of this can be extremely dangerous as there are hardly any medication capable of treating it. By proving to be the first FDA approved drug to treat Melanoma effectively, this medication has truly won hearts of many. Here the melanoma tumors are attacked skillfully. To check its effectiveness, there was an international study conducted where around 676 patients were studied. The conclusion of the research clearly stated that Yervoy could surely postpone the threat caused by Melanoma when taken in combination with other therapy. However there might be adverse effects associated with this disorder that has to be made aware to the patients who might consume this drug. For this purpose, there will be a guide that will talk about all the necessary facts that the consumer has to be made aware of before the ingestion.

Lupus nephritis to be cured by a FDA approved drug

For the first time in 50 years, there is a medication that has been a medication that has been approved by FDA (Food And Drug Administration) for treating Lupus Nephritis. This kidney disorder is a form of systemic lupus systemic lupus erythematosus. Here the immune system is attacked as it is affected.

Till this time, the medications were not being approved as they used to restrain the functions of immune system. When the immune system was affected, it indirectly made the patients suffer from other worse health problems owing to heir weak immunity.

Benlysta was the injectable drug that could cure the disorder without lowering the immunity as it would only try to combat the hyperactive immune system. This is what Dr. Mary Anne Dooley from the University of North Carolina said supporting the FDA approval. However FDA feels that it has not been very beneficial for African Americans and is further into research and studying about this to find a proper medication to cure this disorder in them that might be effectual for them.

Till this time it has been difficult to diagnose and correct this disorder. So, with the innovation of this medication, it has been possible for those suffering from Lupus Nephritis as till this time there was no right medication that could cure it without affecting the body with its adverse effects. Now there is a ray of hope can be seen in those patients who have been desperately and in their diseased condition waiting for a remedy.