Entries in Progesterone (2)


Progesterone Gel Reduces Rate of Premature Birth By 45 Percent

Photodisc/Thinkstock(WASHINGTON) -- The medical community was sent into an uproar recently when KV Pharmaceuticals jacked up the price of 17P, one of the only drugs currently approved to treat preterm birth.  But hope for a new, affordable alternative treatment for certain women at risk of preterm delivery may be on the horizon thanks to new research from the National Institutes of Health.

Unlike 17P, which delivers synthetic progesterone by injection, the drug in question is a naturally-derived progesterone gel applied vaginally.  According to results published Wednesday by the NIH, the gel reduced the rate of preterm birth by 45 percent in women identified as having a short cervix, one of many risk factors for premature delivery.

One of the hardest parts of predicting and treating preterm birth is that early delivery can occur for a number of reasons, and each may require different treatment approaches, says lead author on the study, Dr. Roberto Romero, program head for Perinatology Research and Obstetrics and chief of the Perinatology Research Branch.

One risk factor is having had a preemie baby already -- the risk factor that makes a woman eligible for 17P.  The problem is, about 60 percent of preterm babies come from a mother who does not have a history of preterm birth, so "the question becomes, how else can we assess risk?" says Romero.

This is where testing for a short cervix comes in.  Using a simple ultrasound, doctors can screen for a short cervix during pregnancy and identify a woman as at risk for preterm birth.  By daily applying the gel, which currently costs between $10 and $15 and is prescribed during in vitro fertilization, the rate of these preterm births before the 33rd week of pregnancy can be nearly cut in half.

Though this will only address a small portion of all the preterm births, Romero says that this study argues for universal screening of cervix length to prevent what he estimates will be thousands of premature births annually in the U.S. 

Copyright 2011 ABC News Radio


Price of Preventing Premature Births Skyrockets

Comstock/Thinkstock(NEW YORK) -- Preventing preterm births just got 150 times more expensive, now that KV Pharmaceuticals has gained exclusive rights to produce a progesterone shot used to prevent premature births in high-risk mothers.

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.

Though KV Pharmaceuticals plans to offer financial assistance to low-come households in need of the drug, how private health insurance companies and Medicaid will respond to this price spike remains to be seen, leaving many doctors fearing that access to this treatment will become severely limited or interrupted for those currently mid-treatment.

And because FDA laws prohibit compounding pharmacies from making FDA-approved products, doctors will be legally obligated to stop using the cheaper version of this drug, a representative for the company told ABC News.

KV Pharmaceutical's response to the price controversy has been to announce a Comprehensive Patient Assistance Program for Makena in which households, both insured and uninsured, making less than $100,000 a year will be subsidized.

In a statement to ABC News, drugmakers KV Pharmaceuticals and partner company Ther-Rx, write: "We are committed to taking the appropriate steps to help ensure that all clinically-eligible patients have access to Makena."

This translates into providing the drug for free to households making less than $60,000 annually who "apply for and are eligible for patient assistance." Those making $60,000 to $100,000 will be able to obtain it "at a cost that is comparable to the average copay assigned by commercial insurance," and those who are insured and make less than $100,000 will have a copay of $20 or less guaranteed to them, according to a company statement.

Dr. Alan Fleischman, medical director of the March of Dimes, which supported the FDA approval, says that the company has promised to make Makena available to all, regardless of ability to pay and the March of Dimes "stands ready to watch that process and hold them to their promise."

Copyright 2011 ABC News Radio 

ABC News Radio