Indian Approval of UDEZIRE

TRADE NAME IN INDIA – UDEZIRE 
Erectile dysfunction (ED) is an inability to achieve or sustain an erection suitablefor sexual intercourse. Sexologists say at least 10% men in India may have to use these drugs at some point. Studies have shown that 40% of men up to the age of 40 years have ED andit goesup 70% by 60 years. 

The commonly prescribed drugs for the disorder in India are sildenafil(Viagra) and tadalafil,which belong to a category called phosphodiesterasetype5 drugs. Now, Zydus, a pharmaceutical company, has got exclusive permission to sell udenafil.

It’s not always that the release of a drug is celebrated by many, particularly men. A drug that was released in India last week is the recent in the list of drugs that has a cure for erectile dysfunction. The manufacturers say udenafil, which will be marketed under the brand name Udezire, will be long-acting, but with minimal side effects.

Erectile dysfunction (ED) is an inability to achieve or sustain an erection suitable for sexual intercourse. Sexologists say at least 10% men in India may have to use these drugs at some point. Studies have shown that 40% of men up to the age of 40 years have ED and it goes up 70% by 60 years

Other ED drugs

There are only five oral drugs approved by the FDA to treat erectile dysfunction:CialisLevitra, Staxyn, Stendra, and Viagra. All work by increasing the flow of blood into the penis so that when a man is sexually stimulated, he can get an erection.

What Are the Differences Between Cialis, Levitra, Staxyn, Stendra, and Viagra?

Cialis, Levitra, Staxyn, Stendra, and Viagra work by a similar mechanism to cause erections. There are subtle differences in how long the drug works and how quickly it works. Levitra works a little longer than Viagra. They both take effect in about 30 minutes. With Levitra, the effects last for about 5 hours. With Viagra, the effects last approximately 4 hours.

Cialis works a bit faster (within about 15 minutes), and the effects last much longer — up to 36 hours in some cases. Stendra can start working in as little as 15 minutes and last up to 6 hours. Staxyn is an orally disintegrating tablet that contains the same active ingredient as Levitra but is not interchangeable with Levitra tablets.

If One of These Drugs Isn’t Effective for Erectile Dysfunction, Can I Try Another?

Yes, but because these drugs work the same way, it’s unlikely that you’ll have success with one if you’ve failed to achieve an adequate erection with another.

What Precautions Should I Take Before Taking One of These Drugs?

There are certain situations in which these drugs may not be safe to take. Before taking them, tell your doctor:

  • If you are allergic to any drugs, including Viagra or other ED medications.
  • About any prescription or nonprescription medications you are currently taking, including herbal and dietary supplements.
  • If you are scheduled for surgery, including dental surgery.
  • If you take nitroglycerin or a long-acting nitrate to treat chest pain. The combination of Cialis, Levitra, Staxyn, Stendra, or Viagra with these drugs can cause dangerously low blood pressure.
  • If you take alpha-blockers for blood pressure or prostate problems. The combination of Cialis, Levitra, Staxyn, Stendra, or Viagra with these drugs can also cause dangerously low blood pressure. Patients should not be started on Staxyn unless they have previously taken Levitra as directed by their doctor.
  • Be careful when ordering drugs online from internet pharmacies.  Many medicines sold on websites are counterfeit ED drugs.

In addition, always follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part that you do not understand. Take these drugs exactly as directed. Do not take more or less or take it more often than prescribed by your doctor. Do not take these drugs more than once a day.

Who Should Not Take Cialis, Levitra, Staxyn, Stendra, or Viagra?

If you have suffered from a heart attackstroke or life threatening arrhythmia(irregular heart rate) within the last 6 months you should discuss other options with your doctor. It is also advised to avoid these drugs if you have uncontrolled high or low blood pressure or if you experience chest pain with sex.

US Approval

Holder of Zydena patent in United States, North America, Mexico, and Russia: Dong-A PharmTech is a new drug development company that holds the patent for Zydena (Udenafil: erectile dysfunction treatment) in four regions (e.g., North America, Mexico, Russia).

  1. Upfront payments from licensing out Zydena to local pharmaceutical firms (e.g.,Warner Chilcot, Nycomed);
  2. commission income from milestone payments and running royalties from sales. 2010 OR came in at KRW24.4bn (up 32%YoY), OP at KRW17.5bn (up 35%YoY), and NP at KRW16.4bn (up 42%YoY). Global erectile dysfunction treatment market estimated at USD410mn (18% CAGR): The global market for erectile dysfunction treatments grew at a CAGR of 18% in 2005-10 and reached USD410mn in 2010. Major products include Viagra (46% of the total market), Cialis (40%), and Levitra (14%). Avanafil will be available in the US market sometime late 2012.  Of note, long-acting products such as Cialis are growing rapidly, bolstered by increasing popularity among users and developments in the methods of daily usage. Zydena to hit US market in 2013: Dong-A PharmTech plans to finish Phase III clinical trials for Zydena in 2012 and apply to the US FDA for new drug approval. Upon attaining approval, the company will be able to launch Zydena in the US in 2013.

Zydena’s share of the US market looks set to expand in view of the following:

  • generics for Viagra will not be launched in the US before 2019, when Viagra’s patent expires;
  • Zydena is a long-acting drug like Cialis but is more cost competitive than Cialis.
  • Application for approval to fuel profit recovery in 2012:
  • income following the application of Zydena for FDA approval and royalty income from Russia.

Udenafil / Zydena

Udenafil like Sildenafil, Tadalafil, Avanafil,  and Vardenafil (Viagra®, Cialis®, Stendra ® and Levitra® respectively) is an orally taken PDE-5 inhibitor. Its function is very similar in that it blocks the action of phosphodiesterase type 5 and relieves erectile dysfunction in men.

Zydena ED treatmentUdenafil is produced by Dong-A PharmTech Co Ltd. from Korea and has actually been used there since Nov 2005 and marketed as Zydena® and has since been approved for use in Russia in 2008. An indication that it may indeed prove to be a factor in the ED medication mix in the US one day.

Advantages

  • rapid and predictable onset of action
  • provides necessary to erection hardness
  • increases the axial load on the penis
  • reduces the time of the refractory period (time after ejaculation until the next erection)
  • optimal duration of up to 24 hours
  • high safety profile in the class of PDE-5 inhibitors
  • Drinking alcohol and fatty food does not affect the action of Udenafil

Availability

Although Russian and Malaysian men have access to Zydena, countries such as the US, Europe and Canada might be in for a longer wait. Approval processes in these countries go through phases and are much more detailed and complex.

Udenafil Dosing and Administration

Pills taken by mouth, with or without food, for 30 minutes before the alleged sexual activity.

Recommended dose – 100 mg. If necessary, taking into account individual performance and portability, the dose may be increased to 200 mg. The maximum recommended frequency of application – 1 times / day.

Research

News out in Nov 9th 2009 reveals that Dong-A- PharmTech Co Ltd and its US partner Warner Chilcott have initiated phase 3 testing here in the United States. It includes approximately 1120 patients currently suffering from Erectile Dysfunction. These testing will be double bind, randomized with a placebo to carefully study its effectiveness and being careful not to show a bias.

Original studies in Korea showed that in a 12 weeks scientific study that there was a reported 92% penetration success rate versus 53% for the placebo. The overall patient experience also was rated at a 89% satisfaction verses the placebo satisfaction rate or 26%. It had a fairly rapid onset to be able to compete with existing ED treatments and had a long duration of up to 24 hours. Side effects reported where similar to Sildenafil or Tadalafil with some patients experiencing skin flushing and or headache.

What benefit does a drug like Udenafil have over Sildenafil, Tadalafil, Vardenafil or other experimental treatments like Avanafil? It would be how it interacts with each individual. Udenafil would provide an alternative to existing forms of treatment if accepted. Everyone’s body chemistry interacts differently on some scale with medications introduced. For this reason, Udenafil may prove to “work better” for one individual over another. Also related is someone’s sexual profile and habits, the onset speed and how long it lasts may favor someone over another. Clinically it has to be centered on the patient along with follow up on how it seems to be working.

In 2009 Dong-A Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. announced  that it had completed a 240 patient once-a-day dosing clinical study of udenafil, its new long acting phosphodiesterase type 5 (PDE-5) inhibitor for erectile dysfunction (ED). The multi-center study conducted in Korea was a randomized, double-blind, placebo-controlled study, designed to investigate the efficacy and safety of udenafil in patients with ED. Following a 4-week non-drug baseline period, 240 men with ED of broad etiology and severity were randomized to one of four treatment groups: Placebo, udenafil 25 mg, udenafil 50 mg or udenafil 75 mg. Patients took one tablet a day for 12 weeks with evaluations every 4 weeks. The primary efficacy endpoint was the change in the standard International Index of Erectile Function (IIEF) Erectile Function Domain (EF) score from baseline to final visit. The secondary efficacy endpoints were the change from the baseline in the mean vaginal penetration success rates and mean intercourse completion rates calculated from the Sexual Encounter Profile (SEP) questions 2 and 3. In addition a sub-group analysis was conducted to determine efficacy in the patients that had lower urinary tract symptoms associated with benign prostatic hyperplasia in addition to erectile dysfunction.